Cruxx
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. Responsibilities
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 Requirements
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.
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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. Responsibilities
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 Requirements
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.
#J-18808-Ljbffr