Senior Quality Engineer, Medical Devices & Compliance

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

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.