QMS Analyst

Contract Length: 12 months

Pay Rate: $35-$40/hr

Location: Burlingame, CA (onsite, relocation considered)

About the Role

As a Quality System Analyst, you will take on a critical role in bringing medical device compliance to AR/VR products. You will work side-by-side with quality, engineering, and business teams that are leading innovation in this exciting new product category. The Quality System Analyst will support product programs by executing and implementing Standard Operating Procedures, Work Instructions, and Records from product concept through obsolescence. You will operate in regulated environments (e.g., ISO 13485, US FDA QSR/820) with minimal supervision, demonstrating flexibility, responsiveness, attention to detail, and the ability to manage competing demands.

Responsibilities

• Support the Quality Management System (QMS) needs, including execution of processes such as document management, CSV processing, nonconformance, CAPA, supplier qualification and monitoring, process monitoring, internal audits, and medical device product complaint management.
• Create and release complaint quality system SOPs, Work Instructions (WI), Templates, and records to support business needs for new product introduction and product sustainment.
• Ensure documentation and data related to QMS requirements are controlled to maintain integrity and accessibility.
• Collaboratively communicate quality system requirements between Operations, Supply Chain, and Engineering to facilitate compliance with applicable medical device standards.
• Maintain all applicable records such as validation reports, test reports, exit reviews, and test results, as defined by regulations and standards.
• Support audits by external bodies for licensure and accreditation document submission.
• Manage and organize complex projects and priorities, solve problems impacting release progress, and provide detailed information to cross-functional teams.
• Support the implementation of a new electronic Quality Management System (eQMS).

Requirements

• 5+ years of related experience in a high-tech, fast-paced, consumer electronics environment managing medical device Quality Management System documentation and records.
• Experience with Teamcenter or related PLM/Document Management systems.
• Experience working in a regulated Medical Device environment.
• Familiarity with ISO 13485 and Google Suite.

Benefits

• Supplemental benefits including medical, dental, vision, life, and disability insurance plans.
• Employee Stock Purchase Program (ESPP).
• 401K program with company match after 12 months of tenure.
• Health Savings Account (HSA) on the HDHP plan.
• SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions.
• Corporate discount savings program and other discounts.
• On-demand training program, access to certification prep, and a library of technical and leadership courses/books/seminars after 6+ months of tenure.
• Certification discounts and perks for associations such as CompTIA and IIBA.
• Dedicated customer service team and a certified Career Coach for consultants.