Description
Quality Expert for Medical Devices (m/f)
Reference: -en
Start: 05/18
Duration: 6 MM++
Main tasks:
- 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
Main qualifications
- 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
Main advantages:
- Possibility to be extended
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.