[Skip to main content](#main-content) [OpenNash Jobs](https://jobs.opennash.com/) [Hiring report](/reports/hiring/) · [All Tata Consultancy Services jobs](https://jobs.opennash.com/companies/tata-consultancy-services/) · [Search jobs](/search/) Tata Consultancy Services · Santa Clara, CA # Senior Quality Engineer Santa Clara, CA Senior individual contributor $120,000- $140,000 Manufacturing & Production Last seen on Tata Consultancy Services’s official careers site on August 1, 2026; it may have closed since. [Apply on Tata Consultancy Services’s careers site →](https://ibegin.tcsapps.com/candidate/jobs/421928J) [OpenNash Jobs](https://jobs.opennash.com/) / [Tata Consultancy Services](https://jobs.opennash.com/companies/tata-consultancy-services/) / Senior Quality Engineer ## Job 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 & Certificatio n & 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. #LI-SP1