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Qualitätsmanager, Zulassungsmanager, Projektmanager im Bereich Medizintechnik und Fahrzeugtechnik

Waldshut-Tiengen, Deutschland

Weltweit

MBA Compliance and Risk Management

Waldshut-Tiengen, Deutschland

Weltweit

MBA Compliance and Risk Management

Profilanlagen

Skills

Fahrzeugtechnik FMEA Projektmanager Qualitätsmanagement Prozessberater Audit Lieferkettensorgfaltspflichtengesetz Regulatory Affairs Regulatory Compliance Riskmanagement Change Management MDR FDA SFDA MDSAP DIN EN ISO 13485 IEC 60601 Serie IEC 62304 Medizintecnik ISO 14971 Risikomanagement ISO 14971 IEC 62304 IEC 62366 PFMEA CAD SAP ERP GAP-Analyse LkSG und Umsetzung CSRD ISO 10993 ISO 11607 Anlagen Qualifizierung Validierung ISO27001 ISO9001 Clinical Evaluation Audit DSGVO ISO 19011 EU-DSGVO Compliance Management Verification and Validation Process Improvement Leadership Coaching Teamleader Hinweisgebersystem •Complaint handling Menschenrechte iso 14155 MDR 2017/745 CFR Title 21 Part 820 & 11 FDA 21 cfr part 820 ISO27000 ISO31000 ISO 37301 ethylenoxid Sterilisation Post market surveillance PSURs/PBRERs Vigilance MEDDEV 2.7 Cyber security Azure Windchill agile Nonconformities Supplier Quality Management Supplier Audit SUPPLIER QUALIFICATION Lieferkettenstrategie Medizinproduktezulassung Medizinprodukte aktive und nicht aktive Medizinprodukte In Vitro Diagnostics Sterilverpackung Australien Südkorea China und Türkei Spezialist brasilien EUDAMED techniche Dokumentation CE-Registrierung FDA Regulation)

Profile – Mustafa Dinc | Dinc Consulting
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

Industry Experience:

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

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

Languages:
German (native), Turkish (native), English (Upper Intermediate - Fluent)
IT Skills:
SAP, MS Project, Minitab, Tableau, Agile, Master Control, CAD, Project Management
Academic Background:

MBA in Compliance & Risk Management
Master's thesis on the German Supply Chain Due Diligence Act (LkSG)
Submitted: March 10, 2025 – Result expected: April 2025

Website

Sprachen

DeutschverhandlungssicherEnglischgutTürkischMuttersprache

Projekthistorie

Consulting about Quality Management, Regulatory Affairs, Clinical Evaluation, Project Management, Validation regarding Medical Products.

Dinc Consulting (Own Company) Waldshut-Tiengen DE

Pharma und Medizintechnik

< 10 Mitarbeiter

Dinc Consulting (Own Company) Bad Neustadt DE FEB 13 - NOW

Consulting about Quality Management, Regulatory Affairs, Clinical Evaluation, Project Management, Validation regarding Medical Products.

Freelance Consultant Nonconformities, Medical Device Risk Class III

Abiomed Europe GmbH / J&J Medtech

Pharma und Medizintechnik

250-500 Mitarbeiter

Technical environment & methodologies:
Non-surgical heart pump

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.

CAPA Manager (Interim Solution):

Osyka AG - Rheinfelden

Pharma und Medizintechnik

50-250 Mitarbeiter

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

Technical environment & methodologies:

Electrophysiology

Interventional Cardiology
Pacing
OEM Services

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