I'm working on an exciting opportunity with one of my leading clients in the medical device industry; the team is currently seeking a Senior Quality Engineer to join their growing team. This role is 5x a week onsite in Carlsbad, CA and below are some topline details on the role;
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.
- Write and/or review V&V protocols and reports and perform statistical analysis of data.
- Hands-on collaborator with R&D and MFG – in the lab for testing and investigations, collaborate on design, etc.
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 (eg. IEC 60601).
- Experience with ultrasound/acoustics preferred.
- Able to perform on a fast paced, high visibility project.
Interested in learning more? Apply today for a confidential conversation - send CV or reach out to Vanessa Eatz at vanessa.eatz@peoplewithchemistry.com
