Quality System Specialist (Fremont)

Quality Systems Specialist Medical Devices

Onsite 3 Days | Bay Area, CA | ~20% Travel

We are seeking a Quality Systems Specialist to join a growing medical device organization. This role is critical to supporting, maintaining, and improving the Quality Management System (QMS) in line with international regulatory standards.

What Youll Do

• Maintain and improve QMS procedures, work instructions, processes, and records
• Support supplier quality activities, including selection, qualification, and ongoing evaluations
• Collaborate with R&D and Operations on inspections, non-conformances, and supplier issues
• Contribute to CAPA investigations, root cause analysis, and effectiveness checks
• Support training programs, audits (internal & external), and management reviews

What Were Looking For

This is a great opportunity to play a key role in ensuring compliance and quality excellence in a highly regulated environment.

If youre passionate about driving quality in medical devices and want to make an impact, wed love to hear from you.