Senior Quality Engineer

Tata Consultancy Services; Santa Clara (CA); On-site; USD 120,000 - 140,000; Full time

Benefits offered by this job

Discretionary Incentive

Medical Coverage

Family Leave

Insurance Options

Certifications & Training Reimb.

Vacation & Holidays

Legal & Financial Assistance

Job summary

Tata Consultancy Services is seeking a seasoned Quality Systems professional to oversee regulatory compliance for medical devices. The role focusses on ISO 13485, FDA 21 CFR 820, and design transfer activities for a surgical robotics platform.

Responsibilities include driving CAPA, managing NCs, and leading FMEA throughout product lifecycles, ensuring manufacturing readiness and QMS alignment with regulatory requirements.

Qualifications

• Bachelor’s degree required in a relevant field (e.g., Computer Science) with strong understanding of quality systems.
• Experience with medical device regulatory requirements (FDA QSR and ISO 13485) and design transfer.
• Proven experience with CAPA, NC management, and internal/external audits.
• FMEA experience and proficiency in statistical methods for risk assessment and reliability.

Responsibilities

• Lead design transfer and production support activities, ensuring compliance with FDA/ISO 13485.
• Own subassemblies for a surgical robotics platform, ensuring design integrity and manufacturability.
• Investigate non-conformances using root cause analysis and drive CAPA within QMS.
• Develop and maintain FMEAs, support risk mitigation, and lead IQ/OQ/PQ activities.
• Identify compliant, alternative solutions to engineering challenges and drive continuous improvement.
• Support and maintain 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.

Skills

Quality Systems

Regulatory Compliance

ISO 13485

FDA 21 CFR 820

Design Transfer

CAPA & NC

FMEA

DOE

Statistical Analysis

Education

Bachelor of Computer Science

Job description

Job Description

• 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
• 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

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.

Qualifications

BACHELOR OF COMPUTER SCIENCE