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Quality & Validation Expert (fmd)
Job Location:
Monthly Salary:
Posted:
15 October 2026 (8 days ago)
Posted:
Application Deadline:
12 January 2027
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
Your responsibilities:
- Lead FDA remediation and compliance activities for Class III medical devices / combination products ensuring sustainable resolution of compliance gaps and regulatory observations.
- Provide subject matter expertise in Design Verification & Validation (DVV) test method validation manufacturing controls lot release and risk-based product development.
- Translate FDA feedback Q-Sub outcomes and regulatory requirements into practical testing validation quality and manufacturing actions.
- Partner with Quality Regulatory Affairs R&D Manufacturing and external experts to strengthen FDA inspection readiness QMS effectiveness and overall compliance.
Your qualifications:
- Advanced degree in Engineering Biotechnology Life Sciences or a related field.
- Several years of experience in FDA-regulated combination products.
- Demonstrated hands-on expertise in DVV test method validation process validation QMS and FDA combination product requirements (21 CFR Part 4).
- Strong working knowledge of FDA regulations and FDA remediation or inspection readiness programs with the ability to provide practical solution-oriented guidance.
What we offer:
- An interdisciplinary position with significant responsibility and ample room for initiative
- Short decision-making processes and an open collaborative company culture
- The opportunity to work on innovative medical technologies with high clinical relevance
- A motivated team with strong technical expertise and a shared vision
Any questions
If you have any questions Ms. Kocamahhul would be happy to answer them please do give her a call on 49 (0)!
