Melanie S.-Director Quality Assurance
Check rate
Experience
Lead Quality / Regulatory
Confidential
Built and drove the implementation of an ISO 13485-aligned quality management system for a newly established medical-device manufacturer developing products for leading OEM customers. Led RA/QA strategy, QMS architecture, design-control setup, supplier-...
Director Quality Assurance
Flen Pharma NV
Product range: Class I, IIa & b Alginate GMP production
- Department lead, responsible for product /QMS compliance and safety
- Lead Auditor 1st and 2nd party
- QMS Process Trainer
- eQMS implementation
- Regulatory SME for market access across the glo...
Senior Quality manager, Teamlead & Delegate Head of RA &CA
ZEISS Vision Care
Product range: Class I, Im & IIa - non-implant ophthalmology
- Auditor (1st & 2nd party)
- MDSAP Consultant / Trainer
- MDR Project Implementation for 2 entities (9001 & 13485/ MDSAP)
- QMS responsible incl. Production control and design transfer activ...
Quality engineer, Risk validation engineer
Cochlear Limited
Product range: Class III active, sterile Cochlear Implants
- Sterile Production (ISO Class 5) - responsible Production and Supplier QM
- Person of regulatory Compliance for subassembly manufacturing
- Lead Auditor (1st & 2nd party)
- MDSAP - Preparatio...
Lead Regulatory Affairs / Quality Management Medical Devices
KREWI Medical Produkte GmbH
Product Range: Class I non-implant MD wound care (e.g. Revamil), disinfecting, emergency care
- Staff unit alongside the CEO / Lead ISO 13485, MDD, GMP and GDP
- Supplier audits, contract and risk management
- Post Market Surveillance, CAPA Management,...
Regulatory & Quality Assurance Mgr. DE - AU - CH
Stryker GmbH & Co. KG
Product range: Class I - Class III, non-active osteo- and orthopaedic implants and non-implant instruments.
- Maintenance of the QMS ISO 9001 / 14971
- Manager of 5 employees
- CAPA Management , Management Reviews
- Education management in cooperation ...
QA/RA Specialist
Stryker SA, European Headquarter
- North Europe support for quality management systems
- Development and Implementation of process improvements
- Project manager for region-independent complaint handling
- Recalls, Product Holds, Complaint Handling
Industry Experience
See where this freelancer has spent most of their professional time.
Experienced in Healthcare, Manufacturing, and Pharmaceutical.
Business Area Experience
See which departments and functions this freelancer has contributed to most.
Experienced in Operations, Quality Assurance, Project Management, Product Development, Production, and Audit.
Summary
I help medical-device companies move from regulatory ambition to operational reality by building practical, audit-ready QMS structures and driving the teams, workflows, and evidence needed for certification and market readiness.
Skills
- Qms Strategy, Architecture, Implementation, And Remediation
- Iso 13485, Mdr, Mdsap, Iso 14971, Fda, Taiwan, Japan Regulatory Alignment
- Audit And Certification Readiness For Medical-Device Manufacturers
- Notified Body, Customer, Supplier, And Inter...
Languages
Education
German Sports University Cologne
Master of Science · Economics and Management · Cologne, Germany
Master study in Economics and Management with the focus on Quality Management in non-profit Organisations.
Certifications & licenses
Lead Auditor 13485
BSI
3rd Party Notified Body Auditor Qualification
IRCA Lead Auditor
DIN 10514 Responsible Person
Authorized Representative Quality
TÜV
Statistics
Experience
Global Experience
Expertise
Qualifications
Profile
Frequently asked questions
Have questions? Find more information here.
Daily Rate Distribution
The rates shown represent the typical market range for freelancers in this position based on recent contracts on our platform.
Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.
Average rates for similar positions
Rates are based on recent contracts and do not include FRATCH margin.
The average daily rate is the mean of all daily rates from recent contracts of comparable freelancers on our platform.
The median daily rate is the middle value of all daily rates — half of comparable freelancers charge less, half charge more. Unlike the average, it is barely affected by outliers.
Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.
Similar Freelancers
Discover other experts with similar qualifications and experience
Hans Spichiger
Benjamin Kraus
Andreas Seidl
Manuel Kathofer
Marcel Maurer
Timur Güvercinci
Monika Weber
Gerd Gembatzke
Jürgen Schmickler
Jean Schikora
Experts recently working on similar projects
Freelancers with hands-on experience in comparable project as a Lead Quality / Regulatory
Estelle Kamwa
Paul Van marcke
Andreas Seidl
Klaus Finneiser
Frank Heinemann
Lars Koste
Thomas Freudemann
Philip Scott
Oliver Wulf
Juergen Mehring
Nearby freelancers
Professionals working in or nearby Meerbusch, Germany
Peter Sachs-Witzel
Felix Bauchspiess
Dirk Volkmann
Rudolf Eggelbusch
Alwin Freelancer
Fadi Shoaa
Marcus Wolf
Matthias Bullmahn
Henry Hanau
Antje Baumann
Most recent projects
FRATCH works with many companies and recruitment agencies. Here you will find our recently posted projects and opportunities.
