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Quality System Specialist (Fremont)

Quality System Specialist (Fremont)

CruxxFremont, CA, US
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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

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

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    Quality Specialist • Fremont, CA, US

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