Quality & RA Consultant | EU MDR, ISO 13485, ISO 14971, FDA, Usability, Complaint-Manag,, PMS, CAPA
Waldshut-Tiengen, Deutschland
Weltweit
MBA Compliance and Risk Management
Waldshut-Tiengen, Deutschland
Weltweit
MBA Compliance and Risk Management
Profilanlagen
CV_DINCON_Mustafa_Dinc_EN_Rev01.pdf
CV_DINCON_Mustafa_Dinc_Rev01.pdf
DINCON_Mustafa Dinc_Projektübersicht_Rev01.pdf
DINCON_Mustafa_Dinc_Project_Overview_EN_Rev01.pdf
DINCON_A5_Brochure_English_R01.pdf
DINCON_A5_Broschuere_R01.pdf
Über mich
Erfahrener Quality & Regulatory Affairs Consultant für Medizintechnik. Schwerpunkte: EU MDR, ISO 13485, ISO 14971, FDA, CAPA, PMS, Complaint Handling, Validierung und Audits. Ich unterstütze Unternehmen praxisnah bei Compliance, QMS-Optimierung und regulatorischen Herausforderungen.
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
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
International Pharmaceutical and Medical Device Company (confidential)
Pharma und Medizintechnik
1000-5000 Mitarbeiter
Senior Consultant in Quality Management & Regulatory Affairs with a focus on active, non-invasive Class IIa medical devices, including AI-enabled wearables, sensors, smartphone apps and cloud-based components.
I support manufacturers and distributors in the regulatory and quality assessment of complex supply, distribution and service chains in Germany and across Europe. Key areas include EU MDR 2017/745, ISO 13485, ISO 14971, MDCG guidance, MPDG, MPBetreibV, MPAV, SGB V, as well as vigilance and FSCA requirements.
My services include QMS and gap assessments, evaluation of economic operator roles and responsibilities, development of efficient corporate/local QMS models, RACI matrices, SOP and process concepts, and risk-based action and evidence plans.
I focus on practical, compliant and audit-ready solutions – from regulatory assessment and QMS design to local process implementation, interface controls and pre-launch readiness.
International Manufacturer of Dental Implants (confidential)
Pharma und Medizintechnik
10-50 Mitarbeiter
Senior Consultant in Quality Management & Regulatory Affairs with experience in dental implants and sterile/reusable accessories (Classes IIb, Is and Ir).
I support medical device manufacturers with the remediation of Notified Body findings, technical documentation, supplier quality and regulatory compliance under EU MDR 2017/745. My expertise includes ISO 13485, ISO 14971, GSPR compliance, MDR Annexes I–III, sterilization, packaging and supplier qualification.
Key activities include reviewing and remediating technical documentation, strengthening GSPR traceability, evaluating critical and outsourced suppliers, assessing qualification and audit evidence, and developing risk-based action plans.
I work closely with Quality, Regulatory, Purchasing and external partners to structure complex remediation programs, prioritize regulatory-critical issues and deliver audit-ready documentation efficiently. My projects have included ISO 22441 and ISO 11607 requirements for sterilization and packaging processes.
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 DEFEB 13 - NOW
Consulting about Quality Management, Regulatory Affairs, Clinical Evaluation, Project Management, Validation regarding Medical Products.
Senior Consultant in Quality Management & Regulatory Affairs with experience in active medical devices (Class IIb under EU MDR / Class II under FDA requirements).
I support medical device manufacturers in preparing regulatory documentation, strengthening QMS structures and achieving readiness for FDA submissions and external product testing. My expertise includes ISO 13485, EU MDR 2017/745, FDA 510(k) readiness, IEC 60601-1, IEC 60601-1-2, IEC 62366 and IEC 62304.
Key activities include planning and preparing electrical safety and EMC testing, identifying and closing documentation gaps, supporting regulatory strategy and FDA readiness, and facilitating quality and regulatory workshops with cross-functional teams.
I focus on quickly understanding complex technical and regulatory environments, structuring unclear or incomplete documentation, and developing practical, audit- and submission-ready solutions. Clients value my technical expertise, structured approach and ability to become productive quickly in demanding projects.
Consultant Quality, Regulatory Affairs and Supplier Quality · Jungingen, Germany
Bosch + Sohn GmbH & Co. KG (boso)
Pharma und Medizintechnik
50-250 Mitarbeiter
Senior Consultant in Quality Management & Regulatory Affairs with extensive experience in blood pressure monitors and related accessories, covering medical devices from Class I (Im, Ir) to Class IIa.
I support medical device manufacturers in resolving audit findings, reducing quality record backlogs and further developing QMS structures in line with EU MDR 2017/745 and ISO 13485. My expertise includes ISO 14971, CAPA, complaint handling, supplier quality, change management, UDI, biocompatibility and Post-Market Surveillance.
Key activities include processing and reducing NC/QAB, CAPA and complaint backlogs, implementing audit-related actions, optimizing supplier management and incoming inspection, and improving change control and QMS documentation.
I also support MDR compliance for legacy devices, technical documentation, UDI implementation using GS1/HIBC and selected PMS activities, complemented by practical workshops and training.
My work focuses on measurable process improvements, efficient implementation and sustainable QMS structures that strengthen both quality and regulatory compliance.
Freelance Consultant Nonconformities, Medical Device Risk Class III
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
Senior Quality Engineer
Maquet Cardiopulmonary GmbH - Raststatt DE
Pharma und Medizintechnik
250-500 Mitarbeiter
Quality Management 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
Technical environment & methodologies:
Perfusion technology
Oxygenator
Quality Management - Project Leader
DePuy Synthes - Tuttlingen - Johnson & Jonson
Pharma und Medizintechnik
250-500 Mitarbeiter
QUALITY Management – 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
Technical environment & methodologies
Surgery
Surgical Instruments
Test Method Validation in the Production Area
IQ, OQ, PQ of the CNC Machine in the Production Area
Statistical Methods in Minitab
Project plan
Site Master Validation Plan
Bio Compatibility Test
Product packaging
Sourcing Quality Engineer and Supplier Quality Engineer
DePuy Synthes - Tuttlingen - Johnson & Johnson
Pharma und Medizintechnik
50-250 Mitarbeiter
Purchasing – 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 storerooms.
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
Technical environment & methodologies
Surgery
Surgical Instrument class I-II
Audit Preparation for DIN EN ISO 13485:2016 update as well as Medical Device Directive
Medical Service GmbH Bad Liebenzell
Pharma und Medizintechnik
50-250 Mitarbeiter
Quality Management – Project Leader
Audit Preparation for DIN EN ISO 13485:2016 update as well as Medical Device Directive
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
Technical environment & methodologies
Urology
Catheter
Product Packaging DIN EN ISO 11607
Quality Engineering Consultant for Manufacturing Transfer (Active Medical Device)
Stryker Leibinger GmbH & Co. KG - Freiburg DE
Pharma und Medizintechnik
250-500 Mitarbeiter
Quality Management Quality Engineering Consultant for Manufacturing Transfer (Active Medical Device)
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.
Technical environment & methodologies
Image guided Therapies
Head of Post Market Surveillance & Operational Quality
Schiller AG -Baar CH
Pharma und Medizintechnik
250-500 Mitarbeiter
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 ofPost Market Surveillance Plan for class II-III active medical electrical devices (Art. 84) • Creation ofPost 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)
Technical environment & methodologies:
Active Medical Devices
Blood Pressure Analysis
Electrocardiography
Lung Function Testing
HL7 Applications
Spirometry
Ergo Spirometry (Cardiopulmonary Exercise Testing)
Bodyplethismogrphy
Senior Quality Engineer
Ma1uet Cardiopulmonary GmbH - Hechingen DE
Pharma und Medizintechnik
250-500 Mitarbeiter
Quality Management 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
Technical environment & methodologies:
Perfusion technology
Oxygenator
Quality Management – Leadership: CAPA Process and CAPA Coordination
Roche PVT GmbH Waiblingen DE
Pharma und Medizintechnik
250-500 Mitarbeiter
Quality Management – Leadership: 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)
Quality Management – Leadership: 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
Technical environment & methodologies:
Passive Medical Devices Class I-III
Surgery
Surgical Technics
Surgical Instruments and Implants for the specific therapies
Quality Management 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
Technical environment & methodologies:
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
Technical environment & methodologies:
Passive Medical Devices class I-III
Surgery
Surgical Instruments and Implants for the specific therapies
Quality Management Quality Engineer / FMEA Moderator
PREH GmbH - Bad Neustadt DE
Pharma und Medizintechnik
500-1000 Mitarbeiter
Quality Management Quality Engineer / FMEA Moderator
Approach & main achievements
Moderation of FMEA during product development process phase and design transfer phase as well as updating of existing FMEAs
Adherence of the defined methodology and ensuring the formal correctness of the FMEA
Ensuring consistency between product and process FMEA
Support of the design experts/development engineers/manufacturing engineers during creation of control plans and reaction plans
Creation of standardized FMEA modules
Monitoring the progress of the FMEA projects
Documentation, approval and archiving of FMEA.
Technical environment & methodologies:
Automotive
Manufacturing of the Multimedia Device for the cars
Injection Molding of Plastic
Quality Management and Regulatory - Leadership Head of Quality Management and Regulatory Affairs:
Ganshorn Medizin Electronic GmbH Bad Neustadt DE
Pharma und Medizintechnik
10-50 Mitarbeiter
Quality Management and Regulatory - Leadership Head of Quality Management and Regulatory Affairs:
The biggest challenges in a small and medium-sized company were to analyze all.
processes in the company and to increase the quality awareness of employees in
the company. This included a lot of persuasion to improve the procedures within the
company.
Approach & main achievements
International product Registration /Regulatory Affairs (Turkey, China, Indonesia, EU(CE), FDA, Russia, Brasil, Korea, Taiwan)
Maintaining and developing of quality management systems according to DIN EN ISO 13485 and ISO 9001
Quality planning and quality assurance
CAPA according to FDA Part 820 and ISO 13485
Risk management according to ISO 14971 (FMEA, APIS)
Occupational Health and Safety Management
Planning and carrying out of internal and external audits.
Supplier Quality Management / complaint handling
Clinical evaluation reports of medical electrical devices class IIa, IIb
Planning and supervising of IEC 60601-1 (3. Edition) validation activities according to IEC 60601-1 (3. Edition), ISO 980, IEC 62304, IEC 62366
Technical environment & methodologies:
Active Medical Devices
Lung Function Testing
Body plethysmography
Cardiopulmonary Testing
Spirometry
Software for the Lung Function Testing Devices
Quality and Process Management Team leader Quality and Change Management:
Volke Consulting GmbH & Co. KG - Munich
Automobil und Fahrzeugbau
1000-5000 Mitarbeiter
Quality and Process Management
Team leader Quality and Change Management:
Approach & main achievements
07.08 – 04.09. Six Sigma, Six Sigma Lean, DFSS in house of Volke Consulting
08.07 – 06.08 Quality control of vehicle transmission projects during the series
01.07 – 07.07 Control of the launch in the vehicle project with temporary employment abroad (England/Goodwood)
01.06 – 06.08 Power train development of V8, V12 as change manager
07.03 – 12.05 Change and quality manager in hydrogen vehicle project
05.02 – 06.03 Process optimization, transparency, cost reduction by changes with the focus whole vehicle project
02.01 – 04.02 Project operational strength and materials as test engineer
Technical environment & methodologies:
Engineering
Consulting
Testing
Automotive
Zertifikate
Künstliche Intelligenz (KI) in der Medizintechnik
TÜV SÜD AKADEMIE
2026
Technical Documentation – MDR Annexes II & III
DQSGLOBAL.COM
2026
Compliance Management System
Hochschule Burgenland
2025
Risk Management
Hochschule Burgenland
2025
Generative KI
Hochschule Burgenland
2025
Lieferkettensorgfaltspflichtengesetz
Hochschule Burgenland
2025
MBA in Compliance and Risk Management
Hochschule Burgenland
2025
Sustainability
Hochschule Burgenland
2025
Klinische Bewertung von Medizinprodukten
DIN-Akademie
2022
EU MDR 2017/745
TÜV SÜD Akademie
2017
EU MDR Post Market Surveillance and PMCF
TT Group
2017
EN ISO 13485:2016
Pates Experts / Lütcke Consulting GmbH
2016
SAP
Roche
2016
CAPA and Complaint Handling
Roche Diagnostic
2016
Risk Management
Roche Diagnostic
2016
Software Quality and FDA The Lean
Imbus Akademie
2011
Supplier Quality
GE Healthscare Germany
2011
QM-Anford. bei der Zul. von Medizinpr. in den USA
TÜV SÜD Akademie
2011
Aufbaukurs 510(k)s
TÜV SÜD Akademie
2011
Zulassung von Medizinprodukten in USA Basiskurs
TÜV SÜD Akademie
2011
Europäisches Qualitäts- und Projektmanagement
WBS Trainings AG
2009
Interne/r Auditor/in ISO 9001
Dekra Akademie GmbH
2009
Qualitätsmanagementbeauftragter
DEKRA Akademie GmbH
2009
FMEA Moderator APIS
APIS Informationstechnologien GmbH
2008
Finite Elemente Technik Ansys
Staatliche Technikerschule München
2002
Portfolio
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