Quality System Specialist
CruxxAlameda, CA, US16 hours ago
Job type
- Full-time
Job descriptionBachelor’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.
Job Description
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
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.
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Quality Specialist • Alameda, CA, US