Quality Expert for Medical Devices (m/f)

REFERENZNUMMER:

305947/11

IHRE AUFGABEN:

-Manage portfolio of assigned projects, support a discipline and/or provide a service on your own or with a team of associates
-Provide functional expertise in the area of responsibility for medical devices and combination products
-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
-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
-Perform or support inspections and audits as required
-Meet internal and external guidelines regarding quality and safety (quality manuals, regulatory cGMP guidelines, health authority requirements, SOPs, HSE, etc.)
-Promote and enforce compliance with guidelines

IHRE QUALIFIKATIONEN:

-Degree in Chemistry, Pharmacy, Microbiology or Biotechnology or in another related science
-Solid relevant experience
-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
-Good and proven ability to analyse and evaluate GMP compliance
-English fluent in speaking/writing, German and/or French desirable

WEITERE QUALIFIKATIONEN:

Quality management employee