Title: Senior Quality Assurance Engineer
Location: San Jose, CA (Onsite)
Compensation: Starting at $140,000
Summary: I've recently partnered with the Head of QA 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.. They're on the hunt for a Sr. Quality Assurance Engineer to join their dynamic team!
Qualifications:
- 5+ years of quality experience in the medical device realm (or Master's degree and 3+ years)
- Experience working with electro-mechanical medical devices, robotics, or medical software is highly desired.
- Strong knowledge of FDA requirements for design control of medical devices and 21 CFR 820, ISO 13485, 14971; IEC 60601-1, Cybersecurity, and related regulations
- Experience addressing supplier or process issues (CAPAs, NCMR/NCRs, SCARs, etc.)
Responsibilities:
- Implement and maintain Quality Management System processes, procedures, and techniques.
- Provide quality support for medical device R&D and manufacturing activities throughout all phases of the product development process (e.g. requirement development, specification development, verification and validation testing, design transfer, risk assessment, usability, design change control).
- Participate and support the development of product design history file and ensure compliance to internal processes and external standards and regulations.
- Direct interaction with suppliers to qualify and maintain approved supplier status, as well as oversee supplier process validation activities. May be required to evaluate supplier notification of change and recommend necessary actions to maintain compliance
