Title: Staff/Principal Quality Engineer
Location: San Jose, CA (Onsite)
Description:
We've recently partnered with the Head of QA/RA of a medical device company in San Jose with a diverse portfolio of innovative products; one of which is a wearable device that tracks vital health metrics.. Our companies have worked together on the recruitment front since 2022, with 15 different placements across their R&D, clinical operations, and quality teams. Safe to say the commitment is there! They're looking to onboard a principal-level quality engineer to join the team ASAP.
Qualifications:
- Understanding of regulatory requirements (FDA regulations, ISO 13485, and other relevant standards)
- Proficient in risk management methodologies such as FMEA and HACCP
- The ability to develop, implement, and maintain a robust Quality Management System
- Work closely with the R&D, manufacturing, regulatory affairs, and supply chain teams to lead quality initiatives.
Compensation package:
- Benefits
- 401k
- Paternity/Maternity leave
- Generous PTO
- Onsite parking
