1988 - 1994
RWTH Aachen
Abschluss: Diplom-Ingenieur der Elektrotechnik
Schwerpunkt
Sicherheitsbeauftragter/Medizinprodukteberater gemäß §30, 31
Digitalisierung
Verantwortliche Person nach Artikel 15 MDR
QMB ? Qualitäts-Management-Beauftragter
ISO 13485, ISO 9001 (QMS und Lead Auditor)
Lean Six Sigma ? Green Belt
Projekt-Management
Process & Business Excellence
Budget & Kostenstellen-Management & Investitionen
1994-04 - 1997-12
TÜV Rheinland Japan/ Hongkong - Zertifizierung
Interim Management - JnJ Group - Integration / PAA / FDA & Supplier Management
Suppliers auditing and Development (including follow-up and tracking of all NC`s resp. CAPAs)
? Training of Suppliers in terms of NC, CAPA and Provision of responses
? Establishing of Supplier Quality Assurance Agreements and its criticality Assignment (CL1-CL4)
? Hands-on CAPA work & carrying out risk and QN assessments ? Development and Implementation of a Supplier Plan Strategy (from 100% Inspection to AQL)
? Improvement and Implementation of SPQ Process (Supplier Part Qualifications, FAI / NPI)
? Development and Implementation of WSS (Workmanship Standards) ? ?translation? of Article Specifications / drawings into easy to digest standards for the suppliers
? Establishing of Supplier Scorecards and reporting into the Board (quarterly)
? Managing supplier relationships, enforcing strict standards for incoming materials and components to preserve product integrity and minimize rejections.
? Facilitating communication between departments regarding quality concerns, fostering collaboration towards shared goals.
? Hands-on review and carrying out potential escalations in the NC and CAPA area, carrying out root cause investigations and implementing corrective and preventive actions
? Improvement/implementation of SPC and reporting
? Upgrade of meaningful KPI`s, which reflect the productivity and corresponding countermeasures can be derived from them
? Support of all Abiomed departments in case of any questions ? contact person
? Team Leader of a group of external consultants
? Updated SOP`s to improve the efficiency of the QMS (Such as SPQ Process)
Professional summary:
Results-driven, pragmatic professional drives performance improvements and leads strategic initiatives with solid experience in leadership roles.
Adept at implementing strategic business plans, driving growth, and improving operations.
Skilled in financial management and stakeholder relations.
Collaborative and dedicated to building and leading talented and motivated individuals.
Professional Skills:
? ISO 13485
? ISO 9001
? EU Regulation 2017/745
Medical Device Regulation
MDR
? QMSR Transition FDA
? Supplier Management SQM
? Lead Auditor
? 21 CFR Part 820 QSR FDA
? GMP
? HACCP
? Risk Management ISO 14971
? Project Management
? Six Sigma Green Belt
? Technical Documentation
? KPI
? CAPA Management
? Education / Training / Consulting
? Quality Management Representative (QMB)
Personal Skills:
? Business Analysis
? Resilience
? Self-Reliance
? Stakeholder
Management
? Change
Management
? Problem Solving / Results Based
? Process Improvement
? Attention to Detail / Structures
? Analytical, Methodical, Transparent
? Decision Maker
? Listener / Walk the Talk
? Coach / team oriented
? Inspirational
Software Skills:
? Microsoft Office
? Babtec
? ERP-Infor
? Personio
? Atoss
? Enaio
? HR-Works
? SAP
? DMS
? Trackwise
? ETQ
Automobil
Luft- und Raumfahrt
Medizintechnik
1988 - 1994
RWTH Aachen
Abschluss: Diplom-Ingenieur der Elektrotechnik
Schwerpunkt
Sicherheitsbeauftragter/Medizinprodukteberater gemäß §30, 31
Digitalisierung
Verantwortliche Person nach Artikel 15 MDR
QMB ? Qualitäts-Management-Beauftragter
ISO 13485, ISO 9001 (QMS und Lead Auditor)
Lean Six Sigma ? Green Belt
Projekt-Management
Process & Business Excellence
Budget & Kostenstellen-Management & Investitionen
1994-04 - 1997-12
TÜV Rheinland Japan/ Hongkong - Zertifizierung
Interim Management - JnJ Group - Integration / PAA / FDA & Supplier Management
Suppliers auditing and Development (including follow-up and tracking of all NC`s resp. CAPAs)
? Training of Suppliers in terms of NC, CAPA and Provision of responses
? Establishing of Supplier Quality Assurance Agreements and its criticality Assignment (CL1-CL4)
? Hands-on CAPA work & carrying out risk and QN assessments ? Development and Implementation of a Supplier Plan Strategy (from 100% Inspection to AQL)
? Improvement and Implementation of SPQ Process (Supplier Part Qualifications, FAI / NPI)
? Development and Implementation of WSS (Workmanship Standards) ? ?translation? of Article Specifications / drawings into easy to digest standards for the suppliers
? Establishing of Supplier Scorecards and reporting into the Board (quarterly)
? Managing supplier relationships, enforcing strict standards for incoming materials and components to preserve product integrity and minimize rejections.
? Facilitating communication between departments regarding quality concerns, fostering collaboration towards shared goals.
? Hands-on review and carrying out potential escalations in the NC and CAPA area, carrying out root cause investigations and implementing corrective and preventive actions
? Improvement/implementation of SPC and reporting
? Upgrade of meaningful KPI`s, which reflect the productivity and corresponding countermeasures can be derived from them
? Support of all Abiomed departments in case of any questions ? contact person
? Team Leader of a group of external consultants
? Updated SOP`s to improve the efficiency of the QMS (Such as SPQ Process)
Professional summary:
Results-driven, pragmatic professional drives performance improvements and leads strategic initiatives with solid experience in leadership roles.
Adept at implementing strategic business plans, driving growth, and improving operations.
Skilled in financial management and stakeholder relations.
Collaborative and dedicated to building and leading talented and motivated individuals.
Professional Skills:
? ISO 13485
? ISO 9001
? EU Regulation 2017/745
Medical Device Regulation
MDR
? QMSR Transition FDA
? Supplier Management SQM
? Lead Auditor
? 21 CFR Part 820 QSR FDA
? GMP
? HACCP
? Risk Management ISO 14971
? Project Management
? Six Sigma Green Belt
? Technical Documentation
? KPI
? CAPA Management
? Education / Training / Consulting
? Quality Management Representative (QMB)
Personal Skills:
? Business Analysis
? Resilience
? Self-Reliance
? Stakeholder
Management
? Change
Management
? Problem Solving / Results Based
? Process Improvement
? Attention to Detail / Structures
? Analytical, Methodical, Transparent
? Decision Maker
? Listener / Walk the Talk
? Coach / team oriented
? Inspirational
Software Skills:
? Microsoft Office
? Babtec
? ERP-Infor
? Personio
? Atoss
? Enaio
? HR-Works
? SAP
? DMS
? Trackwise
? ETQ
Automobil
Luft- und Raumfahrt
Medizintechnik