Beschreibung
QA Validation Specialist - Munich - 6 Month Contract - €90/hrOptimus Life Sciences are in partnership with a leading medical device company based in Munich, Germany, looking to recruit an experience QA Validation Specialist on an initial 6-month contract.
The role will focus on the Quality Management System, in relation to EMEA & FDA requirements. This is a role for an advanced contractor who will be able to make an immediate impact on the team.
Tasks
- Supporting the Process Validation projects, making sure that activities are compliant with QMS and external guidelines (FDA amp; EU).
- Facilitate risk assessment/FMEA process. Review and approve validation plans and reports and lab manufacturing equipment qualification (IQ/OQ/PQ).
- Perform QMS maintenance activities and implement quality improvement activities.
- Provide GMP guidance.
Requirements
- 5 years' experience working within a Medical Device or IVD company.
- Excellent knowledge of ISO13485 and US CFR Part 820 cGMP regulation and MD/ IVD legislation in EU and USA.
- Proven experience in process analysis and method validation and experience in risk management, six sigma tools and applied statistic methods.
- Complete fluency in English language with German speakers greatly preferred.
If your profile fits these requirements, then apply by sending me the most recent version of your CV and we can arrange a time to talk on the phone about your suitability.