Medical Device Validation Specialist

vor 5 Stunden


Le Locle, Neuenburg, Schweiz Integra Lifesciences Switzerland SAS Vollzeit

Join us at Integra Lifesciences Switzerland SAS, where we strive to make a positive impact on people's lives through innovative solutions. As a Validation Engineer II, you will play a vital role in ensuring the quality and safety of our medical devices.

About the Job

This position involves developing and executing qualification/validation protocols to support product testing. You will work closely with project teams to design and implement statistically sound tests, while ensuring compliance with regulatory requirements such as cGMP, cGLP, and QSR.

The ideal candidate will possess 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 value teamwork and collaboration, and this role is no exception. You will participate in FDA inspections, ISO certifications, and customer audits, while working towards a common goal of improving patient outcomes.

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.
Requirements
  • 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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