Posted on Sep 21, 2022 by Actalent
Our client, one of the biggest medical device companies in the world, is looking for a Quality Engineer to use their experience for effective and efficient development, transfer and maintenance of products/processes throughout the product life cycle.
- Champions compliance to applicable Global Regulations and standards (eg QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.
- Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges.
- Approve IQ, OQ, PQ, TMV or Software Validation
- Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
- Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.
- Degree in a Life Sciences/Biotechnology, Chemistry discipline or comparable work experience
- 3-5 years of experience working in Medical Devices
- Experience of quality activities in a GMP environment and good knowledge of related regulatory requirements in the life sciences industry (GAMP 5, 21 CFR part 11,...)
- Good verbal and written skills in English, German is a plus
If you would like to learn more about this opportunity, feel free to reach out to me at (see below)
Job Title: QA Engineer
Location: Solothurn, Switzerland
Job Type: Contract
Aerotek, an Allegis Group company. Allegis Group AG. Registration No. CHE-101.865.121. Aerotek and Actalent Services are companies within the Allegis Group network of companies (collectively referred to as "Allegis Group"). Aerotek, Actalent Services, Aston Carter, EASi, TEKsystems, Stamford Consultants and The Stamford Group are Allegis Group brands. If you apply, your personal data will be processed as described in the Allegis Group Online Privacy Notice available on our website.
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