Specialist Quality Assurance

Tuition reimbursement, the  student debt program, and  education benefit - an affordable and convenient path to getting a bachelor’s degree. This position works out of our Alameda, CA location. This is an onsite role. ready and aligned to FDA QSR, ISO 13485, ISO 14971, MDSAP, and EU MDR and global requirements. Secondary responsibilities may include supporting complaint evaluations and quality reviews, trending and metrics, and audit/inspection readiness as needed.

The role may include responsibility for one or more of the following processes  (Customer/Technical Support, Field Failure Analysis, Manufacturing, R&D, Quality Compliance, Regulatory, Clinical, Marketing) to elevate Complaint evaluation and investigation quality, close knowledge gaps, and drive corrective actions.
** Required Qualifications
** 1 year of experience Working knowledge of 21 CFR 803/820/806, ISO 13485, ISO 14971, MDSAP, EU MDR; strong GDP/GMP documentation discipline

Experience with a
** complaint management system** (e.g., Salesforce, Track Wise or similar) and cross‑functional investigation workflows. Demonstrated ability to
** prioritize independently**, make sound regulatory decisions, and communicate clearly and professionally across functions. Proficiency in
** Preferred Qualifications
** 3+ years of experience in medical device complaint handling and/or post‑market surveillance in a regulated environment Familiarity with
** data trending and root****‑
**** cause methodologies** (DMAIC, 5 Whys, Fishbone) and basic statistics/SPC; experience with MAUDE searches a plus. A detail-oriented individual with a 'can do' attitude and the ability to work in a team environment as well as individually (with minimal supervision).Ability to work in a fast-paced environment with multiple tasks/projects. Experience supporting
** audits/inspections
** as an SME.
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