Description
We are looking for a
Quality Expert for Medical Devices / Combination Products (m/f)
Reference: -en
Start: 09/16
Duration: 6 MM+
Place: in Bavaria
Branch: Pharmazeutische Industrie
Your tasks:
- Write, Review and approve deliverables (e.g. procedures, records, third party work, contractors, clinical trial material, components) and related tools (e.g. IT, document systems, training tools, facility validation) to ensure GMP compliance
- Accountable for monitoring, analysis and reporting of GMP related KPIs as part of management reporting
- Manage quality problems and technical matters and ensure they are resolved consistently and in accordance with global standards and policies
- Release of medical devices for clinical studies and commercial use
- Support Medical Device Risk Management through proactive risk management tools and approaches to minimize impact on global supplies and patients
- Represent MD Quality in initiatives and cross-divisional projects
Your qualifications
- Degree in Chemistry, Pharmacy, Microbiology or Biotechnology or another related science
- Fluency in English (speaking), German and/or French desirable
- Sound scientific, technical and regulatory knowledge in a specific area
- Excellent knowledge of cGMP, working knowledge of medical device and combination product regulations, standards and guidelines
- Good knowledge of medical device development and life-cycle management
Skills:
- Quality manager