Beschreibung
QA Engineer - Combination Products (m/f/d)
Reference: -en
Start: asap
Duration: 6 MM+
Main tasks:
- Support the assigned combination product development project(s) from the Design Quality perspective. Ensure that all design development work meets applicable FDA and EU MDR requirements. Ensure that the development teams follows established Design Controls process.
- Draft, review and/or approve of DHF documentation (e.g. Design Input Requirements; Design Outputs including drawings and specifications; Requirements Traceability Matrix; Design Verification / Validation Summary Reports; Design Transfer Plan; Design Change forms, etc.)
- Lead Risk Management (RM) activities, as required by Design Controls process and ISO 14971. Ensure completion of RM documentation required for DHFs.
- Collaborate with the suppliers / CMOs on the following topics: qualification audits; vendor performance issues, deviations and SCARs; review and approval of drawings, specs and test reports; Quality Agreements; process validation, equipment qualification, etc.
- Provide regular progress reports and escalate potential risks related to Quality System and/or project status to Quality management and stakeholders.
- Assist with drafting engineering rationales; review and approve, as required.
- Assist with development and implementation of the quality system complaint with 21 CFR Part 4, MDR and other global requirements.
Main qualifications
- Previous experience as Design Quality Engineer / Product Development Engineer
- Experience with Design Control process / ISO 14971
- Previous experience with drug-device combination products (e.g. pre-filled syringes / auto-injectors)
- Strong analytical skills
- Strong communication skills in English (German would be beneficial)
Main advantages:
- Reputable international company
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.
My contact at Hays:
My contact person:
Yves Fabien Deschamps
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