Quality Assurance Engineer
vor 14 Stunden
Integra Lifesciences Switzerland SAS is committed to creating change and shaping the future of healthcare. Our team thinks differently, embracing challenges as opportunities for growth. Every day, we work together to improve outcomes.
About the RoleThis role is a key contributor to our validation and engineering team. As a Validation Engineer II, you will be responsible for developing and executing qualification/validation protocols. You will collaborate with project teams to design and implement statistically sound tests to support product testing.
The ideal candidate will have a strong background in engineering or science, with experience in validation or quality assurance. Proficiency in French and English is required, along with excellent organizational and communication skills. The ability to facilitate Process FMEA and other risk analysis is also essential.
We are looking for a motivated individual who can develop and execute test methods, schedule coordination, and ensure compliance with regulatory requirements such as cGMP, cGLP, and QSR. The successful candidate will also participate in FDA inspections, ISO certifications, and customer audits.
Key Responsibilities- Develop and execute qualification/validation protocols.
- Collaborate with project teams to design and implement statistically sound tests.
- Facilitate Process FMEA and other risk analysis.
- Develop and execute test methods.
- Schedule coordination and material allocation.
- Ensure compliance with regulatory requirements.
- Participate in FDA inspections, ISO certifications, and customer audits.
- Bachelor's degree in engineering or science.
- 2-5 years of experience in validation or quality assurance.
- Fluent in French and English.
- Excellent organizational and communication skills.
- Experience with qualifying medical device manufacturing equipment.
- Strong knowledge of statistical techniques.
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