Consulting services in Quality, Project, and Process Management, Regulatory Affairs, Prod. Registration for the medical device and automotive sectors.
Aktualisiert am 04.04.2025
Profil
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Remote-Arbeit
Verfügbar ab: 02.04.2025
Verfügbar zu: 100%
davon vor Ort: 100%
Qualitymanagement
Regulatory Affairs
Supply Chain Management
Validierung
CSV
CAPA
LkSG
NC
FDA Part 820
EU MDR 2017/745
Qualifiqation
Projektmanagement
Kabelbaumkonstruktion
IEC 60601
IEC 62304
Usability
Labeling
Registration
DIN EN ISO 11607
DIN 13485
ISO 11135
ISO 10993
ISO 11137
Türkish
Muttersprache
German
Muttersprache
English
Upper Intermediate - Fluent

Einsatzorte

Einsatzorte

Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

12 years 2 months
2013-02 - now

Consulting

  • Consulting about Quality Management, Regulatory Affairs, Clinical Evaluation, Project Management, Validation regarding Medical Products.
on Request
Bad Neustadt DE
1 year 10 months
2023-06 - 2025-03

Non-surgical heart pump

Freelance Consultant Nonconformities/Manufacturing Quality Consultant
Freelance Consultant Nonconformities/Manufacturing Quality Consultant
External Manufacturing Quality Consultant: The greatest challenge in this project was to structure and follow up on constantly changing requirements and a large number of non-conformities (of various types and categories) in compliance with regulations within a team.

The following contributions were made:

  • Ensuring compliance with regulations within a team setting proved to be particularly complex.
  • Motivating both engineering and production stakeholders to initiate timely results and closures was essential.
  • Taking ownership of issues by independently analyzing and evaluating the root causes of all types of non-conformities and initiating appropriate corrections and corrective actions.
  • Presenting insights and solutions as best practices to the team.
  • Initiating field assessments, conducting investigations, and presenting the results at a cross-regional level.
  • Contribution to the design and development of quality inspection plans.
  • Medical Device Risk Class: III
  • Technical environment & methodologies: Non-surgical heart pump
Abiomed Europe GmbH / J&J MedTech ? Aachen
4 months
2023-03 - 2023-06

Define and plan implementation of CAPA?s and subsequent ECs

CAPA Manager (Interim Solution) Electrophysiology Interventional Cardiology Pacing ...
CAPA Manager (Interim Solution)
The biggest challenge was that many NC, SCAR and CAPA at the site had to be
processed (paper based) and closed after a defined date in order to meet the FDA,
EN ISO 13485:2016, MDR 2017-745 requirements.
Working in an international environment as a quality consultant:
  • Document non-conformities and CAPAs and register them in database.
  • Maintain CAPA database and provide regular status and trend reporting to management.
  • Monitor due dates, regularly remind responsible staff members, and escalate to management if due dates are exceeded.
  • Schedule and conduct regular CAPA meetings with staff members.
  • Define and plan implementation of CAPA?s and subsequent ECs (effectiveness checks) together with staff members.
  • Take part in, lead and independently conduct root cause analysis.
  • Create and update SOPs related to the CAPA process.
  • Provide training on CAPA system and application of quality tools for root cause analysis to staff members.
  • Represent and explain the company?s CAPA system during internal and external audits.
  • Medical Device Risk Class: ? I-III
Electrophysiology Interventional Cardiology Pacing OEM Services
Osypka AG ? Rheinfelden
2 years 3 months
2020-10 - 2022-12

Consulting and Support during PMS activities according to MDR 2017/745

Ophthalmology
Consulting and Support during PMS activities according to MDR 2017/745 and Quality
Support as Quality Engineer during agile development phases of the Software class
IIa: Working in an international environment as a quality engineering consultant:
  • Cyber Security Risk Management,
  • Risk Based Complaint Handling acc. to DIN EN ISO 13485 as well as acc. to MDR 2017/745
  • CAPA
  • Risk Management
  • PMS Implementation (PMS Plan, PMS Report, PSUR) acc. to MDR 2017/745
  • Creation of PMS and Complaint Trending Reports 
Ophthalmology
Carl Zeiss Meditec AG ? Munich
6 months
2022-01 - 2022-06

Quality Management

Senior Quality Engineer Oxygenator Perfusion technology
Senior Quality Engineer
The biggest challenge was that many NC, SCAR and CAPA at the site had to be
processed (in SAP) and closed after a defined date in order to meet the FDA, EN ISO
13485:2016, MDR 2017-745 requirements.
Approach & main achievements:
  • Clear / concrete definition of NC-Projects (SAP Based)
  • Creation and closing of NCs (including NCR, NC, Complaints, CAPAs, SCARs) e.g.: in the clean room area, power failures, bioburden sterility assurance level, particle level, Material failure, production failure etc.
  • Development and determination of containment, correction and corrective action as well as material disposition, impact assessment and creation of the related documents.
  • Systematic determination of root cause of the non-conformity.
  • Creation of Weekly reports
Oxygenator Perfusion technology
Maquet Cardiopulmunary GmbH ? Raststatt DE
8 months
2019-10 - 2020-05

QUALITY Management

Project Leader Surgery Surgical Instruments Test Method Validation in the Production Area ...
Project Leader
Quality validation engineering and project change management of lubricant
Working in an international environment as a quality validation engineer and project
manager. The biggest challenges were to organize different employees from
different departments with different education levels for the project as well as large
number of articles to analyze and evaluate and to meet the deadlines. Furthermore,
the employees had to be trained for the projects. The environment was technical as
well as on a business level
Approach & main achievements
  • Carrying out of the Validation (IQ, OQ, PQ, Compliance Analysis, Risk Based Validation) for the Manufacturing Machines and Equipment?s
  • Carrying out of Test Method Validation
  • Product Change Management (Technical Files)
  • Creation of Project Management Plan
  • Creation of Site Validation Master Plan
  • Project Leading of Change Management Project Swisscool coolant (lubricant) including change of all concerned technical files.
  • Review and creation of the inspection process and inspection sheets
  • Creation of the Procedure for the environmental condition of the chemicals and substances and supply chain of the chemicals
  • Review and update of the Heat Treatment Procedure for external and internal approach
  • Conducting of Periodic Validation Reports
  • CAPA
Surgery Surgical Instruments Test Method Validation in the Production Area IQ OQ PQ of the CNC Machine Statistical Methods in Minitab Projectplan Site Master Validation Plan Bio Compatibility Test Product packaging
DePuy Synthes - Tuttlingen
1 year
2018-11 - 2019-10

Purchasing

Project Leader/Sourcing Quality Engineer and Supplier Quality Engineer Surgery Surgical Instrument class I-II
Project Leader/Sourcing Quality Engineer and Supplier Quality Engineer

The biggest challenges were integrating the employees with different education.

level into the project and implementing the stable purchasing process according to
the deadlines.
Approach & main achievements
  • ? Analysis, improvement and introduction of purchasing process,
  • ? Analysis, improvement and implementation of purchase ordering process,
  • ? Analysis, improvement and introduction of article master data process,
  • ? Analysis, improvement and implementation of HiBE (Hilfs- und Betriebsstoffe) process,
  • Document processing of DCR and DCO in Agile,
  • Creation and editing of CAPA, NC and Observation in ETQ as owner,
  • Training of employees regarding the introduced purchasing and PP&L procedures.
  • Analysis, improvement of the Approved Supplier List in Tuttlingen
  • Analysis, improvement of the transport packaging and transport handling procedure
  • Project management in the context of CAPA about storage conditions under consideration of regulations regarding chemicals and substances including:
    • Investigation of current status (Gap-analysis).
    • Carrying out risk management regarding HiBE (Hilf- und Betriebsmittel)
    • Introduction of workplace design according to 5S
    • Introduction of the procedure from the receipt of goods to the storage of chemicals and substances in the storeroom
  • Achieved Benefit for the site Tuttlingen:
    • Stable HIBE (Hilfs- und Betriebsmittel) process
    • Compliance with storage conditions for the chemicals
    • Stable ordering process
    • Stable suppliers change process.
    • Stable article master data process
    • Stable order processing process
    • No observation/findings after audits
    • Stable ASL (Approved Supplier List) Procedure
Surgery Surgical Instrument class I-II
DePuy Synthes ? Tuttlingen DE
3 months
2018-08 - 2018-10

Audit Preparation for DIN EN ISO 13485:2016 update as well as Medical Device Directive

Quality Management - Project Leader Urology Catheter Product Packaging DIN EN ISO 11607
Quality Management - Project Leader
The biggest challenge for the project was that the preparation for ISO 13485: 2016 certification audit had to be carried out within 8 weeks.
Approach & main achievements
  • Gap-Analysis of the Risk Management Procedure as well as Risk Management Files (Especially pFMEA)
  • Gap-Analysis of the Process Validation Procedure as well as Process Validation Files (TMV, IQ, OQ, PQ, Packaging, Injection Molding, Sterilization Procedure, CSV)
  • Creation a Quality Improvement Plan
  • Recommendations
Urology Catheter Product Packaging DIN EN ISO 11607
Medical Service GmbH Bad Liebenzell
5 months
2018-03 - 2018-07

Manufacturing Transfer (Active Medical Device)

Quality Engineering Consultant Image guided Therapies
Quality Engineering Consultant
The biggest challenge in the project was the preparation of the production transfer
at a plant in Berlin so that the production of active medical devices in Freiburg could
be guaranteed.
Approach & main achievements
  • Support Manufacturing Transfer by performing quality activities.
  • Creation and Monitoring of engineering and QMS change requests.
  • Transferring NC / CAPA to the site receiving the products and lead the completion of the NC / CAPAs
  • Support of inspection planning and initial sampling (Main focus)
  • Participation in the implementation of the manufacturing process for transferred products.
  • Subject matter expert for process risk analysis and FMEA's
  • Monitoring of critical process validation (welding, gluing, etc.)
  • Support the development and monitoring of processes and equipment validations / qualifications.
Image guided Therapies
Stryker Leibinger GmbH & Co. KG ? Freiburg DE
11 months
2017-04 - 2018-02

Quality Management - Leadership

Head of Post Market Surveillance & Operational Quality Active Medical Devices Blood Pressure Analysis Electrocardiography ...
Head of Post Market Surveillance & Operational Quality
The biggest challenges in the project were the experience in the Regulation of EU
MDR due to new Regulation. The integration into the project was also a challenge
because of the new requirements. A lot of persuasion was necessary because of the
diversity of the project and processes.
Approach & main achievements
  • Introduction of Post Market Surveillance Process according to Medical Device Regulation (2017/745) for class II-III active medical electrical devices (Defibrillators, ECG, Holter ECG, Cardiopulmonary Exercise Testing devices, AEDs, Monitoring Devices, Spirometry Devices, Blood Pressure Measurement Devices):
  • Creation of Post Market Surveillance Plan for class II-III active medical electrical devices (Art. 84)
  • Creation of Post Market Surveillance Report (MDR Article 85)
  • Creation of Periodic Safety Update Report (MDR Article 86)
  • Vigilance Reporting as well as Medical Device Reporting (MDR Article 87-92)
  • Improvement of Complaint Handling Process
  • Improvement of Product CAPA Process
  • Improvement of Product Change Management Process
  • Risk Assessment as well as Risk Management acc. to ISO 14971:2012
  • Creation of Clinical Evaluation Report for active medical electrical devices class II-III acc. to Meddev 2.7.1 Rev4 (7 Reports have been created)
  • Preparation of authority inspection (Swissmedic, FDA, MDSAP, TÜV SÜD)
  • Reporting to Global Product Management
  • Regulatory Affairs (As Regulatory Compliance Manager): Completion of Technical Files for EU (DoC), US (510(k)) as well as Asia Market (China, CFDA)
Active Medical Devices Blood Pressure Analysis Electrocardiography Lung Function Testing HL7 Applications Spirometry Ergo Spirometry (Cardiopulmonary Exercise Testing) Bodyplethismogrphy
Schiller AG ? Baar CH
8 months
2016-10 - 2017-05

Quality Management

Senior Quality Engineer Perfusion technology Oxygenator
Senior Quality Engineer
The biggest challenge was that a large number of NC and CAPA at the site had to be processed and closed after a defined date in order to meet the FDA requirements.
Approach & main achievements
  • Clear / concrete definition of NC-Projects
  • Creation and closing of NCs (including NCR, NC, Complaints, CAPAs) e.g.: in the clean room area, power failures, bioburden sterility assurance level, particle level, Material failure, production failure etc.
  • Development and determination of containment, correction and corrective action as well as material disposition, impact assessment and creation of the related documents.
  • Systematic determination of root cause of the non-conformity.
  • Creation of Weekly reports
Perfusion technology Oxygenator
Maquet Cardiopulmunary GmbH ? Hechingen DE
1 year 1 month
2015-09 - 2016-09

Quality Management ? Leadership

CAPA Process and CAPA Coordination In Vitro Diagnostic Laboratory Systems for In Vitro Diagnostic
CAPA Process and CAPA Coordination
The biggest challenge was that many CAPA at the site had to be processed and closed after a defined date in order to meet the requirements. In addition, employees received regular training during completion of CAPAs.
Approach & main achievements
  • Improvement of CAPA Process
  • Creation of a new SOP for CAPA (successful implemented)
  • CAPA Coordination (Amount of CAPA: 136, 80% were completed)
In Vitro Diagnostic Laboratory Systems for In Vitro Diagnostic
Roche PVT GmbH Waiblingen DE
8 months
2015-01 - 2015-08

Quality Management ? Leadership

DHF Remediation Engineering Consultant Passive Medical Devices Class I-III Surgery Surgical Technics ...
DHF Remediation Engineering Consultant
The biggest challenges in the project were to combine many articles (approx. 2000)
into article families and to remediate the legacy issues.
Approach & main achievements
  • Technical writing-reports and technical justification
  • Carry out DHF remediation activities as per approved remediation plan
  • Develop protocols and procedures
  • Develop understanding in functional / system testing of medical devices
  • Analysing of current Risk Management Process Introduction, improvement, Release of Risk Management Files for the implants and instruments (Trauma and Healing Devices)
  • Analysing, Introduction, Improvement as well as detection of Use Related Hazards / Human Error Factors according to Surgical Techniques
  • Risk Management acc. to DIN EN ISO 14971:2012
  • Introducing of Complaint Summary Reports for Implants and Instruments as well as Risk Management Reports
Passive Medical Devices Class I-III Surgery Surgical Technics Surgical Instruments and Implants for the specific therapies
ZimmerBiomet GmbH - Tuttlingen DE J
3 months
2014-10 - 2014-12

Quality Management

Senior Quality Engineering Consultant/Production Risk Analysis Consultant Passive Medical Devices Class I-III Surgery Surgical Instruments and Implants for the specific therapies
Senior Quality Engineering Consultant/Production Risk Analysis Consultant
The biggest challenges in the project were to combine many articles into article
families and to remediate the legacy issues.
Approach & main achievements
  • Creating of uniform and traceable production risk management analysis for all implants and instruments (with support of further subject matter experts) according to ISO 14971
  • Support the manufacturing sites implementing the production risk analysis process.
  • Creation of standardized FMEA modules and templates 
Passive Medical Devices Class I-III Surgery Surgical Instruments and Implants for the specific therapies
DePuy Synthes GmbH - Hägendorf CH
8 months
2013-11 - 2014-06

Manufacturing Engineering / Validation

GRQP Manufacturing Engineering Consultant/Validation Consultant Passive Medical Devices class I-III Surgery Surgical Instruments and Implants for the specific therapies
GRQP Manufacturing Engineering Consultant/Validation Consultant
The biggest challenges in the project were to combine a large number of articles into
article families and to remediate the legacy issues.
Approach & main achievements
  • Compile a traceable process validation documentation for medical devices in respect of cleanliness and biocompatibility.
  • Support the manufacturing sites implementing the biocompatibility and cleanliness process.
  • Prepare the complete and traceable electronic documentation of the cleanliness validation and biological safety evaluation (part of the Device Master Record (DMR))
  • Review and corporation of manufacturing process validation and test data into documentation management systems
  • Assess the cleanliness and biocompatibility status of existing manufacturing processes (with support of further subject matter experts)
  • Responsible of the conduct of the cleanliness validation in manufacturing
  • Coordination of external cleanliness tests in cooperation with a internal unit (e.g. Cytotoxicity, Bioburden, Fourier, Transform Infrared Spectroscopy (FTIR), Total Organic Carbon (TOC)
  • Documentation of process monitoring processes regarding cleanliness
  • Interface between different functions (manufacturing, process validation, material testing, risk management
Passive Medical Devices class I-III Surgery Surgical Instruments and Implants for the specific therapies
DePuy Synthes GmbH - Zuchwill CH

Aus- und Weiterbildung

Aus- und Weiterbildung

04/2025

MBA in Compliance & Risk Management

Master's thesis: on Request, Submitted: March 13, 2025 ? Result expected: April 2025


Specific training

  • Medical Device Regulation (TÜV SÜD)
  • DIN EN ISO 134585: 2016 (Pates GmbH)
  • Quality Management Representative (DEKRA)
  • Internal Auditor (DEKRA)
  • Quality Management Requirements for medical devices in the US-Market (TÜV SÜD)
  • Creation of 510(k) premarket notification (TÜV SÜD)
  • SAP (DePuy Synthes, ZimmerBiomet, Stryker GmbH, Roche, Maquet)
  • Agile Way ? Software Process for FDA (Inbus Academy)
  • Master Control (Document Management System)
  • Agile (Document Management System)
  • Supplier Quality Collaboration System (GE Healthcare)
  • Bio Compatibility (DePuy Synthes)
  • Packaging (Teleflex)
  • EU MDR Post Market Surveillance and Post Market Clinical Follow Up (TT Group in Brussel)
  • Apis FMEA Moderation (APIS GmbH)

Kompetenzen

Kompetenzen

Top-Skills

Qualitymanagement Regulatory Affairs Supply Chain Management Validierung CSV CAPA LkSG NC FDA Part 820 EU MDR 2017/745 Qualifiqation Projektmanagement Kabelbaumkonstruktion IEC 60601 IEC 62304 Usability Labeling Registration DIN EN ISO 11607 DIN 13485 ISO 11135 ISO 10993 ISO 11137

Schwerpunkte

Quality Management
FDA, DIN EN 13485:2016, DIN EN ISO 9001:2015
Validation
Regulatory Affairs
Leadership
Project Management
Technical Know How
Social Skills
Risk Management
Clinical Evaluation
Post Market Surveillance
Vigilance
Process Improvements
LkSG (German Supply Chain Act)

Produkte / Standards / Erfahrungen / Methoden

SAP
MS Project
Minitab
Tableau
Agile
Master Control
CAD
Project Management
MS Office
MS Visio
Profile 
Experienced consultant with over 24 years of professional expertise in Quality Management, Regulatory Affairs, Risk Management, and Validation ? specialized in the medical device sector (active and passive devices, software, IVD), automotive industry, and in-vitro diagnostics.


Core Competencies

  • Quality Management in accordance with FDA, ISO 13485, MDSAP, and EU-MDR
  • Regulatory Affairs & CAPA Management
  • Risk Management (ISO 14971, ISO 31000)
  • Validation (IQ, OQ, PQ, Test Method Validation)
  • Post-Market Surveillance (PMS, PSUR, Complaint Handling)
  • Management of complex regulatory and technical projects
  • Implementation of the German Supply Chain Due Diligence Act (LkSG)
  • Leadership and intercultural collaboration

Key Strengths
  • Independent root cause analysis and implementation of solutions for non-conformities
  • Efficient CAPA processes, audit preparation, and support
  • Translating regulatory requirements into technical solutions
  • Development and implementation of best practices
  • International project work with cross-functional teams


Professional experience

  • 24 Years: Quality Management
  • 8 Years: Regulatory Affairs
  • 16 Years: Risk Management
  • 5 Years: Validation
  • 14 Years: Project Management
  • 16 Years: CAPA
  • 15 Years: FDA
  • 8 Years : EU-MDR
  • 9 Years: Active Medical Devices class I-III
  • 7 Years: Passive Medical Devices class i-III
  • 13 Month: In Vitro Diagnostic


Specific area of expertise

  • Quality Management
  • ISO13485, ISO 14971, ISO 10993
  • Validation
  • Post Market Surveillance
  • Regulatory Affairs
  • Risk Management
  • EU-MDR and MDD
  • FDA
  • MDSAP
  • Supplier Quality
  • Project Management
  • Leadership
  • Clinical Evaluation Report
  • IEC 60601, IEC 62366, ISO 15223, IEC 62304, ISO 11135, ISO 11137, ISO 11607
  • ISO 31000
  • ISO 37301
  • ISO 37001
  • ISO 37002
  • ISO 27001
  • LkSG (Supply Chain Act Germany, Master thesis)


Sectors of activity

  • ? Medical Device (Active, Passive, Software)
  • ? Automotive
  • ? In Vitro Diagnostic (Roche)

Branchen

Branchen

  • Medical Devices (Class I?III, active & passive, software)
  • Automotive
  • In-vitro Diagnostics

Einsatzorte

Einsatzorte

Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

12 years 2 months
2013-02 - now

Consulting

  • Consulting about Quality Management, Regulatory Affairs, Clinical Evaluation, Project Management, Validation regarding Medical Products.
on Request
Bad Neustadt DE
1 year 10 months
2023-06 - 2025-03

Non-surgical heart pump

Freelance Consultant Nonconformities/Manufacturing Quality Consultant
Freelance Consultant Nonconformities/Manufacturing Quality Consultant
External Manufacturing Quality Consultant: The greatest challenge in this project was to structure and follow up on constantly changing requirements and a large number of non-conformities (of various types and categories) in compliance with regulations within a team.

The following contributions were made:

  • Ensuring compliance with regulations within a team setting proved to be particularly complex.
  • Motivating both engineering and production stakeholders to initiate timely results and closures was essential.
  • Taking ownership of issues by independently analyzing and evaluating the root causes of all types of non-conformities and initiating appropriate corrections and corrective actions.
  • Presenting insights and solutions as best practices to the team.
  • Initiating field assessments, conducting investigations, and presenting the results at a cross-regional level.
  • Contribution to the design and development of quality inspection plans.
  • Medical Device Risk Class: III
  • Technical environment & methodologies: Non-surgical heart pump
Abiomed Europe GmbH / J&J MedTech ? Aachen
4 months
2023-03 - 2023-06

Define and plan implementation of CAPA?s and subsequent ECs

CAPA Manager (Interim Solution) Electrophysiology Interventional Cardiology Pacing ...
CAPA Manager (Interim Solution)
The biggest challenge was that many NC, SCAR and CAPA at the site had to be
processed (paper based) and closed after a defined date in order to meet the FDA,
EN ISO 13485:2016, MDR 2017-745 requirements.
Working in an international environment as a quality consultant:
  • Document non-conformities and CAPAs and register them in database.
  • Maintain CAPA database and provide regular status and trend reporting to management.
  • Monitor due dates, regularly remind responsible staff members, and escalate to management if due dates are exceeded.
  • Schedule and conduct regular CAPA meetings with staff members.
  • Define and plan implementation of CAPA?s and subsequent ECs (effectiveness checks) together with staff members.
  • Take part in, lead and independently conduct root cause analysis.
  • Create and update SOPs related to the CAPA process.
  • Provide training on CAPA system and application of quality tools for root cause analysis to staff members.
  • Represent and explain the company?s CAPA system during internal and external audits.
  • Medical Device Risk Class: ? I-III
Electrophysiology Interventional Cardiology Pacing OEM Services
Osypka AG ? Rheinfelden
2 years 3 months
2020-10 - 2022-12

Consulting and Support during PMS activities according to MDR 2017/745

Ophthalmology
Consulting and Support during PMS activities according to MDR 2017/745 and Quality
Support as Quality Engineer during agile development phases of the Software class
IIa: Working in an international environment as a quality engineering consultant:
  • Cyber Security Risk Management,
  • Risk Based Complaint Handling acc. to DIN EN ISO 13485 as well as acc. to MDR 2017/745
  • CAPA
  • Risk Management
  • PMS Implementation (PMS Plan, PMS Report, PSUR) acc. to MDR 2017/745
  • Creation of PMS and Complaint Trending Reports 
Ophthalmology
Carl Zeiss Meditec AG ? Munich
6 months
2022-01 - 2022-06

Quality Management

Senior Quality Engineer Oxygenator Perfusion technology
Senior Quality Engineer
The biggest challenge was that many NC, SCAR and CAPA at the site had to be
processed (in SAP) and closed after a defined date in order to meet the FDA, EN ISO
13485:2016, MDR 2017-745 requirements.
Approach & main achievements:
  • Clear / concrete definition of NC-Projects (SAP Based)
  • Creation and closing of NCs (including NCR, NC, Complaints, CAPAs, SCARs) e.g.: in the clean room area, power failures, bioburden sterility assurance level, particle level, Material failure, production failure etc.
  • Development and determination of containment, correction and corrective action as well as material disposition, impact assessment and creation of the related documents.
  • Systematic determination of root cause of the non-conformity.
  • Creation of Weekly reports
Oxygenator Perfusion technology
Maquet Cardiopulmunary GmbH ? Raststatt DE
8 months
2019-10 - 2020-05

QUALITY Management

Project Leader Surgery Surgical Instruments Test Method Validation in the Production Area ...
Project Leader
Quality validation engineering and project change management of lubricant
Working in an international environment as a quality validation engineer and project
manager. The biggest challenges were to organize different employees from
different departments with different education levels for the project as well as large
number of articles to analyze and evaluate and to meet the deadlines. Furthermore,
the employees had to be trained for the projects. The environment was technical as
well as on a business level
Approach & main achievements
  • Carrying out of the Validation (IQ, OQ, PQ, Compliance Analysis, Risk Based Validation) for the Manufacturing Machines and Equipment?s
  • Carrying out of Test Method Validation
  • Product Change Management (Technical Files)
  • Creation of Project Management Plan
  • Creation of Site Validation Master Plan
  • Project Leading of Change Management Project Swisscool coolant (lubricant) including change of all concerned technical files.
  • Review and creation of the inspection process and inspection sheets
  • Creation of the Procedure for the environmental condition of the chemicals and substances and supply chain of the chemicals
  • Review and update of the Heat Treatment Procedure for external and internal approach
  • Conducting of Periodic Validation Reports
  • CAPA
Surgery Surgical Instruments Test Method Validation in the Production Area IQ OQ PQ of the CNC Machine Statistical Methods in Minitab Projectplan Site Master Validation Plan Bio Compatibility Test Product packaging
DePuy Synthes - Tuttlingen
1 year
2018-11 - 2019-10

Purchasing

Project Leader/Sourcing Quality Engineer and Supplier Quality Engineer Surgery Surgical Instrument class I-II
Project Leader/Sourcing Quality Engineer and Supplier Quality Engineer

The biggest challenges were integrating the employees with different education.

level into the project and implementing the stable purchasing process according to
the deadlines.
Approach & main achievements
  • ? Analysis, improvement and introduction of purchasing process,
  • ? Analysis, improvement and implementation of purchase ordering process,
  • ? Analysis, improvement and introduction of article master data process,
  • ? Analysis, improvement and implementation of HiBE (Hilfs- und Betriebsstoffe) process,
  • Document processing of DCR and DCO in Agile,
  • Creation and editing of CAPA, NC and Observation in ETQ as owner,
  • Training of employees regarding the introduced purchasing and PP&L procedures.
  • Analysis, improvement of the Approved Supplier List in Tuttlingen
  • Analysis, improvement of the transport packaging and transport handling procedure
  • Project management in the context of CAPA about storage conditions under consideration of regulations regarding chemicals and substances including:
    • Investigation of current status (Gap-analysis).
    • Carrying out risk management regarding HiBE (Hilf- und Betriebsmittel)
    • Introduction of workplace design according to 5S
    • Introduction of the procedure from the receipt of goods to the storage of chemicals and substances in the storeroom
  • Achieved Benefit for the site Tuttlingen:
    • Stable HIBE (Hilfs- und Betriebsmittel) process
    • Compliance with storage conditions for the chemicals
    • Stable ordering process
    • Stable suppliers change process.
    • Stable article master data process
    • Stable order processing process
    • No observation/findings after audits
    • Stable ASL (Approved Supplier List) Procedure
Surgery Surgical Instrument class I-II
DePuy Synthes ? Tuttlingen DE
3 months
2018-08 - 2018-10

Audit Preparation for DIN EN ISO 13485:2016 update as well as Medical Device Directive

Quality Management - Project Leader Urology Catheter Product Packaging DIN EN ISO 11607
Quality Management - Project Leader
The biggest challenge for the project was that the preparation for ISO 13485: 2016 certification audit had to be carried out within 8 weeks.
Approach & main achievements
  • Gap-Analysis of the Risk Management Procedure as well as Risk Management Files (Especially pFMEA)
  • Gap-Analysis of the Process Validation Procedure as well as Process Validation Files (TMV, IQ, OQ, PQ, Packaging, Injection Molding, Sterilization Procedure, CSV)
  • Creation a Quality Improvement Plan
  • Recommendations
Urology Catheter Product Packaging DIN EN ISO 11607
Medical Service GmbH Bad Liebenzell
5 months
2018-03 - 2018-07

Manufacturing Transfer (Active Medical Device)

Quality Engineering Consultant Image guided Therapies
Quality Engineering Consultant
The biggest challenge in the project was the preparation of the production transfer
at a plant in Berlin so that the production of active medical devices in Freiburg could
be guaranteed.
Approach & main achievements
  • Support Manufacturing Transfer by performing quality activities.
  • Creation and Monitoring of engineering and QMS change requests.
  • Transferring NC / CAPA to the site receiving the products and lead the completion of the NC / CAPAs
  • Support of inspection planning and initial sampling (Main focus)
  • Participation in the implementation of the manufacturing process for transferred products.
  • Subject matter expert for process risk analysis and FMEA's
  • Monitoring of critical process validation (welding, gluing, etc.)
  • Support the development and monitoring of processes and equipment validations / qualifications.
Image guided Therapies
Stryker Leibinger GmbH & Co. KG ? Freiburg DE
11 months
2017-04 - 2018-02

Quality Management - Leadership

Head of Post Market Surveillance & Operational Quality Active Medical Devices Blood Pressure Analysis Electrocardiography ...
Head of Post Market Surveillance & Operational Quality
The biggest challenges in the project were the experience in the Regulation of EU
MDR due to new Regulation. The integration into the project was also a challenge
because of the new requirements. A lot of persuasion was necessary because of the
diversity of the project and processes.
Approach & main achievements
  • Introduction of Post Market Surveillance Process according to Medical Device Regulation (2017/745) for class II-III active medical electrical devices (Defibrillators, ECG, Holter ECG, Cardiopulmonary Exercise Testing devices, AEDs, Monitoring Devices, Spirometry Devices, Blood Pressure Measurement Devices):
  • Creation of Post Market Surveillance Plan for class II-III active medical electrical devices (Art. 84)
  • Creation of Post Market Surveillance Report (MDR Article 85)
  • Creation of Periodic Safety Update Report (MDR Article 86)
  • Vigilance Reporting as well as Medical Device Reporting (MDR Article 87-92)
  • Improvement of Complaint Handling Process
  • Improvement of Product CAPA Process
  • Improvement of Product Change Management Process
  • Risk Assessment as well as Risk Management acc. to ISO 14971:2012
  • Creation of Clinical Evaluation Report for active medical electrical devices class II-III acc. to Meddev 2.7.1 Rev4 (7 Reports have been created)
  • Preparation of authority inspection (Swissmedic, FDA, MDSAP, TÜV SÜD)
  • Reporting to Global Product Management
  • Regulatory Affairs (As Regulatory Compliance Manager): Completion of Technical Files for EU (DoC), US (510(k)) as well as Asia Market (China, CFDA)
Active Medical Devices Blood Pressure Analysis Electrocardiography Lung Function Testing HL7 Applications Spirometry Ergo Spirometry (Cardiopulmonary Exercise Testing) Bodyplethismogrphy
Schiller AG ? Baar CH
8 months
2016-10 - 2017-05

Quality Management

Senior Quality Engineer Perfusion technology Oxygenator
Senior Quality Engineer
The biggest challenge was that a large number of NC and CAPA at the site had to be processed and closed after a defined date in order to meet the FDA requirements.
Approach & main achievements
  • Clear / concrete definition of NC-Projects
  • Creation and closing of NCs (including NCR, NC, Complaints, CAPAs) e.g.: in the clean room area, power failures, bioburden sterility assurance level, particle level, Material failure, production failure etc.
  • Development and determination of containment, correction and corrective action as well as material disposition, impact assessment and creation of the related documents.
  • Systematic determination of root cause of the non-conformity.
  • Creation of Weekly reports
Perfusion technology Oxygenator
Maquet Cardiopulmunary GmbH ? Hechingen DE
1 year 1 month
2015-09 - 2016-09

Quality Management ? Leadership

CAPA Process and CAPA Coordination In Vitro Diagnostic Laboratory Systems for In Vitro Diagnostic
CAPA Process and CAPA Coordination
The biggest challenge was that many CAPA at the site had to be processed and closed after a defined date in order to meet the requirements. In addition, employees received regular training during completion of CAPAs.
Approach & main achievements
  • Improvement of CAPA Process
  • Creation of a new SOP for CAPA (successful implemented)
  • CAPA Coordination (Amount of CAPA: 136, 80% were completed)
In Vitro Diagnostic Laboratory Systems for In Vitro Diagnostic
Roche PVT GmbH Waiblingen DE
8 months
2015-01 - 2015-08

Quality Management ? Leadership

DHF Remediation Engineering Consultant Passive Medical Devices Class I-III Surgery Surgical Technics ...
DHF Remediation Engineering Consultant
The biggest challenges in the project were to combine many articles (approx. 2000)
into article families and to remediate the legacy issues.
Approach & main achievements
  • Technical writing-reports and technical justification
  • Carry out DHF remediation activities as per approved remediation plan
  • Develop protocols and procedures
  • Develop understanding in functional / system testing of medical devices
  • Analysing of current Risk Management Process Introduction, improvement, Release of Risk Management Files for the implants and instruments (Trauma and Healing Devices)
  • Analysing, Introduction, Improvement as well as detection of Use Related Hazards / Human Error Factors according to Surgical Techniques
  • Risk Management acc. to DIN EN ISO 14971:2012
  • Introducing of Complaint Summary Reports for Implants and Instruments as well as Risk Management Reports
Passive Medical Devices Class I-III Surgery Surgical Technics Surgical Instruments and Implants for the specific therapies
ZimmerBiomet GmbH - Tuttlingen DE J
3 months
2014-10 - 2014-12

Quality Management

Senior Quality Engineering Consultant/Production Risk Analysis Consultant Passive Medical Devices Class I-III Surgery Surgical Instruments and Implants for the specific therapies
Senior Quality Engineering Consultant/Production Risk Analysis Consultant
The biggest challenges in the project were to combine many articles into article
families and to remediate the legacy issues.
Approach & main achievements
  • Creating of uniform and traceable production risk management analysis for all implants and instruments (with support of further subject matter experts) according to ISO 14971
  • Support the manufacturing sites implementing the production risk analysis process.
  • Creation of standardized FMEA modules and templates 
Passive Medical Devices Class I-III Surgery Surgical Instruments and Implants for the specific therapies
DePuy Synthes GmbH - Hägendorf CH
8 months
2013-11 - 2014-06

Manufacturing Engineering / Validation

GRQP Manufacturing Engineering Consultant/Validation Consultant Passive Medical Devices class I-III Surgery Surgical Instruments and Implants for the specific therapies
GRQP Manufacturing Engineering Consultant/Validation Consultant
The biggest challenges in the project were to combine a large number of articles into
article families and to remediate the legacy issues.
Approach & main achievements
  • Compile a traceable process validation documentation for medical devices in respect of cleanliness and biocompatibility.
  • Support the manufacturing sites implementing the biocompatibility and cleanliness process.
  • Prepare the complete and traceable electronic documentation of the cleanliness validation and biological safety evaluation (part of the Device Master Record (DMR))
  • Review and corporation of manufacturing process validation and test data into documentation management systems
  • Assess the cleanliness and biocompatibility status of existing manufacturing processes (with support of further subject matter experts)
  • Responsible of the conduct of the cleanliness validation in manufacturing
  • Coordination of external cleanliness tests in cooperation with a internal unit (e.g. Cytotoxicity, Bioburden, Fourier, Transform Infrared Spectroscopy (FTIR), Total Organic Carbon (TOC)
  • Documentation of process monitoring processes regarding cleanliness
  • Interface between different functions (manufacturing, process validation, material testing, risk management
Passive Medical Devices class I-III Surgery Surgical Instruments and Implants for the specific therapies
DePuy Synthes GmbH - Zuchwill CH

Aus- und Weiterbildung

Aus- und Weiterbildung

04/2025

MBA in Compliance & Risk Management

Master's thesis: on Request, Submitted: March 13, 2025 ? Result expected: April 2025


Specific training

  • Medical Device Regulation (TÜV SÜD)
  • DIN EN ISO 134585: 2016 (Pates GmbH)
  • Quality Management Representative (DEKRA)
  • Internal Auditor (DEKRA)
  • Quality Management Requirements for medical devices in the US-Market (TÜV SÜD)
  • Creation of 510(k) premarket notification (TÜV SÜD)
  • SAP (DePuy Synthes, ZimmerBiomet, Stryker GmbH, Roche, Maquet)
  • Agile Way ? Software Process for FDA (Inbus Academy)
  • Master Control (Document Management System)
  • Agile (Document Management System)
  • Supplier Quality Collaboration System (GE Healthcare)
  • Bio Compatibility (DePuy Synthes)
  • Packaging (Teleflex)
  • EU MDR Post Market Surveillance and Post Market Clinical Follow Up (TT Group in Brussel)
  • Apis FMEA Moderation (APIS GmbH)

Kompetenzen

Kompetenzen

Top-Skills

Qualitymanagement Regulatory Affairs Supply Chain Management Validierung CSV CAPA LkSG NC FDA Part 820 EU MDR 2017/745 Qualifiqation Projektmanagement Kabelbaumkonstruktion IEC 60601 IEC 62304 Usability Labeling Registration DIN EN ISO 11607 DIN 13485 ISO 11135 ISO 10993 ISO 11137

Schwerpunkte

Quality Management
FDA, DIN EN 13485:2016, DIN EN ISO 9001:2015
Validation
Regulatory Affairs
Leadership
Project Management
Technical Know How
Social Skills
Risk Management
Clinical Evaluation
Post Market Surveillance
Vigilance
Process Improvements
LkSG (German Supply Chain Act)

Produkte / Standards / Erfahrungen / Methoden

SAP
MS Project
Minitab
Tableau
Agile
Master Control
CAD
Project Management
MS Office
MS Visio
Profile 
Experienced consultant with over 24 years of professional expertise in Quality Management, Regulatory Affairs, Risk Management, and Validation ? specialized in the medical device sector (active and passive devices, software, IVD), automotive industry, and in-vitro diagnostics.


Core Competencies

  • Quality Management in accordance with FDA, ISO 13485, MDSAP, and EU-MDR
  • Regulatory Affairs & CAPA Management
  • Risk Management (ISO 14971, ISO 31000)
  • Validation (IQ, OQ, PQ, Test Method Validation)
  • Post-Market Surveillance (PMS, PSUR, Complaint Handling)
  • Management of complex regulatory and technical projects
  • Implementation of the German Supply Chain Due Diligence Act (LkSG)
  • Leadership and intercultural collaboration

Key Strengths
  • Independent root cause analysis and implementation of solutions for non-conformities
  • Efficient CAPA processes, audit preparation, and support
  • Translating regulatory requirements into technical solutions
  • Development and implementation of best practices
  • International project work with cross-functional teams


Professional experience

  • 24 Years: Quality Management
  • 8 Years: Regulatory Affairs
  • 16 Years: Risk Management
  • 5 Years: Validation
  • 14 Years: Project Management
  • 16 Years: CAPA
  • 15 Years: FDA
  • 8 Years : EU-MDR
  • 9 Years: Active Medical Devices class I-III
  • 7 Years: Passive Medical Devices class i-III
  • 13 Month: In Vitro Diagnostic


Specific area of expertise

  • Quality Management
  • ISO13485, ISO 14971, ISO 10993
  • Validation
  • Post Market Surveillance
  • Regulatory Affairs
  • Risk Management
  • EU-MDR and MDD
  • FDA
  • MDSAP
  • Supplier Quality
  • Project Management
  • Leadership
  • Clinical Evaluation Report
  • IEC 60601, IEC 62366, ISO 15223, IEC 62304, ISO 11135, ISO 11137, ISO 11607
  • ISO 31000
  • ISO 37301
  • ISO 37001
  • ISO 37002
  • ISO 27001
  • LkSG (Supply Chain Act Germany, Master thesis)


Sectors of activity

  • ? Medical Device (Active, Passive, Software)
  • ? Automotive
  • ? In Vitro Diagnostic (Roche)

Branchen

Branchen

  • Medical Devices (Class I?III, active & passive, software)
  • Automotive
  • In-vitro Diagnostics

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