Quality System Specialist

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 You’ll 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 We’re Looking For Bachelor’s degree in engineering, life sciences, or related field 3+ years’ experience in

medical devices, IVDs, or life sciences

within an

FDA/ISO 13485-regulated environment Working knowledge of

FDA QSR, ISO 13485, and EU MDR Experience with

CAPA, auditing, inspections, and document control Proficiency in Microsoft Office Willingness to travel up to 20% and work onsite in 3 days a week in The Bay facility.

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

If you’re passionate about driving quality in medical devices and want to make an impact, we’d love to hear from you.