QA Engineer
Ver: 141
Dia de atualização: 21-03-2024
Localização: Solothurn Solothurn SO
Categoria: Alta tecnologia Mecânico / Técnico Elétrica / Eletrônica IT - Software
Indústria: Research Services
Posição: Entry level
Tipo de empregos: Contract
Conteúdo do emprego
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.Main Responsibilities- 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
Data limite: 05-05-2024
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