Senior Quality Assurance Specialist
3 weeks ago
We are seeking a Senior Quality Assurance Specialist to lead our medical device team in ensuring compliance with FDA and European MDR standards. This role involves quality lead for medical devices from concept to commercial release, ensuring all relevant standards are met.
Key Responsibilities:
- Quality lead for medical devices from concept to commercial release.
- Ensure compliance with all relevant FDA and European MDR standards for electronic/imaging catheters.
- Write and/or review all required documentation, including product specifications, risk analysis, test protocols and reports, etc.
- Collaborate with R&D and MFG teams on design, testing, and investigations.
Requirements:
- Senior/Staff level preferred.
- Proficiency in statistics and Minitab.
- Experience with FDA and MDR design control documentation.
- Experience with design of medical system safety requirements.
- Able to perform on a fast-paced project.
Meet the requirements and take on this challenging role to ensure the highest quality medical devices.
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