Job Description
We are seeking a Senior Quality Engineer to lead our operations quality activities, supporting the commercialization and manufacturing scale-up of new medical devices. This role ensures full compliance with regulatory standards while working closely with contract manufacturers to establish robust production and quality processes.
Key Responsibilities:
* Evaluate product designs for conformity with FDA QSR 21 CFR 820, ISO 13485, ISO 14971, EU MDR regulations; perform risk assessments on electro-mechanical medical devices.
* Develop and implement process validation (IQ/OQ/PQ), equipment qualification plans in collaboration with manufacturing partners.
* Analyze root cause issues through failure mode analysis (FMEA) based methods using Six Sigma principles supported by QA experts as necessary;
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