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Senior Quality Assurance Engineer
1 month ago
We are seeking a highly skilled Senior Quality Engineer to join our team in the medical device industry. This role is based in Carlsbad, CA and involves working on exciting projects from concept to commercial release.
Key Responsibilities:- Lead quality initiatives for medical devices, ensuring compliance with FDA and European MDR standards.
- Develop and review documentation, including product specifications, risk analysis, and test protocols.
- Collaborate with R&D and MFG teams on design and testing.
- Perform statistical analysis and write/review V&V protocols and reports.
- Senior/Staff level experience preferred.
- Proficiency in statistics and Minitab.
- Experience with FDA and MDR design control documentation.
- Knowledge of design of medical system safety requirements.
- Experience with ultrasound/acoustics preferred.
Interested in learning more about this opportunity? Send your CV or reach out to Vanessa Eatz for a confidential conversation.