Quality Engineer

Medical Device EngineerJob Description Must Have Technical/Functional Skills • Strong understanding of Medical Device Quality Systems and regulatory compliance requirements • Working 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 13485 • Sound knowledge of Medical Device Regulations, including MDD and MDR • Proven experience in Non Conformance (NC) management, CAPA processes, and internal/external audits • Expertise in Medical Device Risk Management, with the ability to identify both apparent and less obvious risks • Practical experience with Application, Process, Design, and System FMEA methodologies • Proficient in statistical tools and techniques, including Design of Experiments (DOE) • Capable of performing advanced descriptive and non parametric statistical analyses • Experienced in leveraging advanced statistical methods for reliability prediction and data driven decision making Roles & Responsibilities • Lead 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 requirements • Collaborate with cross functional teams to deliver quality compliant outcomes • Interpret and apply medical device regulations and standards to projects and processes • Support audits and regulatory inspections, ensuring timely closure of actions Salary Range: $120,000- $140,000 a year TCS Employee Benefits Summary: Discretionary Annual Incentive. Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans. Family Support: Maternal & Parental Leaves. Insurance Options: Auto & Home Insurance, Identity Theft Protection. Convenience & Professional Growth: Commuter Benefits & Certification & amp; Training Reimbursement. Time Off: Vacation, Time Off, Sick Leave & Holidays. Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing Location Santa Clara, CA Job Function TECHNOLOGY Role Engineer