Quality Engineer

Role: Quality EngineerLocation: Santa Clara, CA (Hybrid)Fulltime – Permanent Salary - $100K - $140K / YearJob DescriptionMust Have Technical/Functional SkillsStrong understanding of Medical Device Quality Systems and regulatory compliance requirementsWorking knowledge of ISO 13485:2016/2019 and 21 CFR Part 820 (FDA Quality System Regulation)Strong expertise in design transfer activities, including DHF → DMR transition and compliance with FDA 21 CFR 820 & ISO 13485Sound knowledge of Medical Device Regulations, including MDD and MDRProven experience in Non Conformance (NC) management, CAPA processes, and internal/external auditsExpertise in Medical Device Risk Management, with the ability to identify both apparent and less obvious risksPractical experience with Application, Process, Design, and System FMEA methodologiesProficient in statistical tools and techniques, including Design of Experiments (DOE)Capable of performing advanced descriptive and non parametric statistical analysesExperienced in leveraging advanced statistical methods for reliability prediction and data driven decision makingRoles & ResponsibilitiesLead design transfer and production support activities, ensuring compliance with FDA/ISO 13485 and alignment with manufacturing readiness.Own multiple subassemblies for a surgical robotics platform, ensuring design integrity, quality, and manufacturability.Investigate non-conformances (NCs) using root cause analysis and drive CAPA within the QMS framework.Develop and maintain FMEAs, support risk mitigation, and lead manufacturing issue resolution and qualifications (IQ/OQ/PQ).Identify and implement compliant, alternative solutions to engineering and production challenges while driving continuous improvement.Support and maintain Quality Management System (QMS) processes in compliance with regulatory requirementsCollaborate with cross functional teams to deliver quality compliant outcomesInterpret and apply medical device regulations and standards to projects and processesSupport audits and regulatory inspections, ensuring timely closure of actions