Quality Expert for Medical Devices (m/f)

REFERENZNUMMER:

371760/26

IHRE AUFGABEN:

-Ensure technical development and manufacturing operations of assigned Medical Devices/Combination Products are conducted in accordance with Quality System requirements, ensuring high product quality, regulatory compliance and operational efficiency
-Manage portfolio of assigned projects, support a discipline and/or provide a service on his/her own or with a team of associates Provide functional expertise in 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
-Support Medical Device Risk Management, through proactive risk management tools and approaches, to minimize impact on global supplies and patients
-Lead project related activities (e.g. development of new tools, processes)
-Perform or support inspections and audits as required.
-Coach and develop people; participate in recruitment of talent
-Support a culture of high performance and trust
-Assure that the required level of knowledge and skills is available and identify competency gaps
-Establish and implement training and development plans

IHRE QUALIFIKATIONEN:

-Graduate in Chemistry, Pharmacy, Microbiology or Biotechnology or another related science
-English fluent in speaking / writing, German and/or French desirable
-Profound working experience in relevant field
-Ability to influence people, negotiate and communicate
-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 as well as proven ability to analyse and evaluate GMP compliance
-Good knowledge of medical device development and life-cycle management
-Good organizational skills

WEITERE QUALIFIKATIONEN:

Quality management employee