About Our Client
Our client is a global leader in eye health, we are driven by a bold ambition: Vision Made Possible™ shaping a better future for patients of all ages. With a commitment to reaching over 44 million people annually, we strive to improve access to care and address the growing global challenge of poor eye health
Role Description
Quality Assurance support for mechanical and optical laboratory validation projects, ensuring compliance with regulatory standards such as ISO 13485. The current focus is on test method validation for a Smartscope device used to measure components for Intraocular Lens manufacturing.
Responsibilities
- Ensure quality assurance for lab validation projects
- Draft, review, and approve validation plans, protocols, and reports
- Develop and improve test method validations
- Ensure consistent and accurate testing by protocols
- Analyze results using statistical tools (e.g., Minitab)
- Evaluate compliance with lab standards and QMS
Requirements
- Bachelor’s in mechanical engineering, Mechatronics, Physics, Engineering Science, or Bioengineering
- 2–4 years QA experience (preferably in medical/pharma industry)
- Strong knowledge of GMP, ISO 13485, ISO 14971, QSR CFR 820
- Experience with test method validation, metrology, and Smart scope or similar instruments
- Fluent in Dutch and English
Other Information
Apply to our vacancy for more information. Looking forward to hearing from you!
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Since 2012, SIRE Life Sciences is the most innovative and engaged consultancy company for the life sciences industries.
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