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Qualitätsmanagement, Regulatory Affairs, Produktmanagement in Medizintechnik, IVD, Life Sciences (ISO 13485, 14971, 9001; MDR, IVDR, 21 CFR Part 820)

Profil
Top-Skills
Qualitymanagement Regulatory Affairs Sales and Marketing
Verfügbar ab
16.01.2023
Aktuell verfügbar - Der Experte steht für neue Projektangebote zur Verfügung.
Verfügbar zu
50%
davon vor Ort
100%
Einsatzorte
PLZ-Gebiete
Länder
Ganz Deutschland
Remote-Arbeit
möglich
Art des Profiles
Freiberufler / Selbstständiger
Der Experte ist als Einzelperson freiberuflich oder selbstständig tätig.

3 Jahre 1 Monat

2019-08

2022-08

management of two cross-funtional

project manager
Rolle
project manager
Projektinhalte
  • management of two cross-funtional work streams in order to meet regulatory requirements resulting from new EU MDR regulation 2017/745
  • Main focus on EU MDR compliant product labeling and collection of product data as well as maintenance / establishement of internal databases for automated data upload to EUDAMED and FDA-GUDID
  • Coordination of activities with relevant interfaces (e.g. procurement, verification, R&D, production, quality and regulatory affairs) including the set-up of new processes / QM documents based on GAP analyses
Kunde
medical device division of a large global enterprise
2 Jahre 5 Monate

2018-03

2020-07

preparation of the recertification and the transition

quality management consultant
Rolle
quality management consultant
Projektinhalte
  • preparation of the recertification and the transition from ISO 9001:2008 towards ISO 9001:2015
  • conduct of gap analyses related to the transition
  • updating the QM documentation
Kunde
logistics enterprise within the value chain of medical technology
1 Jahr 6 Monate

2018-10

2020-03

preparation of management

quality consultant
Rolle
quality consultant
Projektinhalte
  • review of QM documents
  • performance of internal audits based on ISO 9001 and 14001
  • preparation of management reviews
  • support of external audits
  • follow-up on audit recommendations and findings
Kunde
medium sized chemical compay
10 Monate

2019-03

2019-12

Creation of new and verification of existing

quality and regulatory affairs consultant
Rolle
quality and regulatory affairs consultant
Projektinhalte
  • preparation of trial master file and investigator site files according to ICH-GCP
  • Further development of existing QM system based on ISO 13485, FDA 21CFR part 820, GMP and other regulations / guidelines
  • Creation of new and verification of existing QM documents for EU declaration of conformity
Kunde
quoted lifescience company
7 Monate

2018-09

2019-03

preparation and conduct / support

quality management officer and deputy security officer
Rolle
quality management officer and deputy security officer
Projektinhalte
  • preparation and conduct / support of audits (internal, notified bodies, suppliers, contract manufacturing organisation (CMO)
  • set-up and follow-up of CAPA (focus on appropriateness and accelerated efficiency check)
  • work on deviations, changes and non-compliances due to incorrect specifications (OOS)
  • preparation and moderation of quality meetings and management reviews, preparation of „quality metrics“, revision of QM documents
  • release of raw materials and final products, QM training of employees
Kunde
quoted medium sized medical device company
1 Monat

2018-07

2018-07

preparation, performance and final reporting

internal auditor
Rolle
internal auditor
Projektinhalte
  • preparation, performance and final reporting on outcome with regard to an internal audit based on ISO 13485:2016. Used ISO 19011 as a guideline for auditing
Kunde
medium-sized enterprise in the medical technology
4 Monate

2018-02

2018-05

QM documentation, training of employees

quality management consultant
Rolle
quality management consultant
Projektinhalte
  • updating the QM-system from ISO 13485:2003 to ISO 13485:2016
  • gap-analysis, bringing up to date the QM documentation, training of employees
Kunde
medium-sized company for medical devices
1 Monat

2018-01

2018-01

preparation and conduct

leader of a workshop
Rolle
leader of a workshop
Projektinhalte
  • preparation and conduct of a workshop on the new IVDR EU regulation 2017/746
Kunde
professional organization for companies in medical technology and IVD
3 Monate

2017-10

2017-12

updating the documentation

leader of a project in quality management
Rolle
leader of a project in quality management
Projektinhalte
  • updating the documentation of the QMS (based on ISO 13485, FDA 21 CFR Part 820 etc.)
  • modifications in close cooperation with the different functions
Kunde
global enterprise for medical technology
6 Monate

2017-07

2017-12

preparation and support

quality manager
Rolle
quality manager
Projektinhalte
  • preparation and support of surveillance and transition based on different versions of DIN EN ISO 9001
  • performance of gap analysis
  • preparation, moderation and documentation of management reviews
  • updating the QM documentation
Kunde
software company within the value chain of pharmaceutical and medical device industries
7 Monate

2017-03

2017-09

oordination of tasks in the context

project manager with tasks in marketing and quality management
Rolle
project manager with tasks in marketing and quality management
Projektinhalte
  • setting up the project plan for the launch of an important product
  • coordination of tasks in the context of the global product launch
  • updating the QM documentation based on ISO 13485 und FDA 21 CFR Part 820
Kunde
global manufacturer of active medical products
1 Jahr 4 Monate

2014-06

2015-09

quality management and in regulatory affairs

head of operations
Rolle
head of operations
Projektinhalte
  • development and maintenance of a QM-system based on ISO 13485 following the company’s quality policy
  • pursuing the company’s quality objectives
  • steering the process of improvement
  • evaluation and auditing of suppliers and external parties (risk based conception and guidance)
  • management of complaints
  • risk management based on ISO 14971; steering the CAPA process; setting up of FMEAs
  • cooperation with notified body
  • approval of steps in product realisation after validation and verification of results by R&D engineers
  • steering of company’s interfaces – also within the context of design transfer to production
  • carrying out of internal audits
  • registration of IVD on international markets
Kunde
DiaMex GmbH in Heidelberg, Germany
1 Jahr 3 Monate

2010-03

2011-05

performed in quality management

head of marketing
Rolle
head of marketing
Projektinhalte
  • development and maintenance of a QM-system based on ISO 9001 and ISO 13485 following the company’s quality policy
  • pursuing the company’s quality objectives
  • management of complaints
  • evaluation and auditing of suppliers and external parties
  • carrying out of internal audits
Kunde
Becton Dickinson GmbH, subunit diagnostic systems, in Heidelberg, Germany
4 Jahre 3 Monate

2003-04

2007-06

performed in quality management

business unit manager
Rolle
business unit manager
Projektinhalte
  • development and maintenance of a QM-system based on ISO 9001 following the company’s quality policy
  • pursuing the company’s quality objectives
  • steering the process of continuous improvement
  • maintenance of business unit’s quality management manual
  • evaluation and auditing of suppliers and external parties
  • carrying out of internal audits
  • support of customers in pharmaceutical industry within the qualification process (DQ, IQ, OQ, PQ) related to industrial microbiology
Kunde
bioMérieux Deutschland GmbH in Nürtingen, Germany
4 Jahre 1 Monat

1999-03

2003-03

performed in quality management

product manager
Rolle
product manager
Projektinhalte
  • first implementation of a QM-Systems based on ISO 9001
  • setting up of business processes
  • creation of QM documentation: process descriptions, working instructions, forms
  • training of employees
  • management of complaints
  • evaluation and auditing of suppliers and external parties
  • carrying out of internal audits
  • incoming goods inspection for local buffer warehouse
  • participation in ring trials for external quality assessment of IVD products
Kunde
Chemie AG in Berlin, Germany

Project history shortened - older projects gladly on request

07/2012

graduated as an M.B.A. general management at the University of Applied Sciences in Ludwigshafen, Germany

 

09/1999

graduated as a doctor scientiarum humanarum (» Ph.D.) at the University of Heidelberg, Germany

 

10/1985 ? 08/1988 

study of biology at the universities of Münster, Heidelberg and Frankfurt a.M. (all in Germany), graduated as a biologist with diploma

10/1990 ? 08/1993

study of biology at the universities of Münster, Heidelberg and Frankfurt a.M. (all in Germany), graduated as a biologist with diploma

certified vocational trainings

06/2019

workshop ?validation of processes in the medical industry? at Vorest AG in Stuttgart, Germany

 

05/2019

seminar ?medical device regulation (MDR) ? qualified person (person responsible for regulatory compliance)? at TÜV Süd Akademie GmbH in Filderstadt, Germany

 

03/2018

seminar ?medical device single audit program (MDSAP)? at DQS Medizinprodukte GmbH in Frankfurt a.M., Germany

 

07/2016

training course ?internal auditor EN ISO 13485:2016? at Vorest AG in Pforzheim, Germany

 

12/2016

seminar ?FDA requirements for Medical Devices in the USA (21 CFR Part 820) and quality system regulation (QSR)? at Vorest AG in Pforzheim, Germany

 

12/2016

training course ?ISO 14971 ? risk management? at Vorest AG in Pforzheim, Germany

 

12/2016

recertification as a lean management & six sigma professional black belt at Alphadi Akademie in Kassel, Germany

 

10/2013 ? 11/2013

qualification as a lean management & six sigma professional black belt at Alphadi Akademie in Kassel, Germany

English very good

Top Skills
Qualitymanagement Regulatory Affairs Sales and Marketing
Produkte / Standards / Erfahrungen / Methoden
Edraw
strong knowledge
 Microsoft-Office Minitab MS Project MS SharePoint MS Visio PaintShop
strong knowledge

working experience

02/2018 - today

Role: independant consultant

Customer: consilio et opera GmbH in Waghäusel, Germany (same purpose of the company as consilio et opera Lempert Consulting (please see below))

 

10/2013 ? 03/2015

Role: guest lecturer for general management

Customer: the Baden-Wuerttemberg Cooperative State University in Heilbronn, Germany

Task

  • academic training of bachelor students ? including project management tools:
    e.g., stakeholder analysis, gap-analysis, swim lane-concept for process documentation, FMEA, Gantt chart etc.

 

06/2011 ? 01/2018

Role: independant consultant  in life sciences

Customer:medical technology and in-vitro diagnostics industries in Sandhausen, Germany

 

07/2007 ? 03/2010

Role: foundation and steering of a consultancy ageny

Customer: online shop at terralogo.com Limited & Co. KG in Sandhausen, Germany

 

Task

tasks performed as self-employed freelancer in quality management: please see excerpt from project list below

Life Sciences, MedTech, medical technology, medical devices, In-vitro-diagnostics

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