Quality Expert for Medical Devices / Combination Products (m/f)

REFERENZNUMMER:

312786/1

IHRE AUFGABEN:

-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

IHRE QUALIFIKATIONEN:

-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

WEITERE QUALIFIKATIONEN:

Quality manager