Norm and Compliance Engineer

Tata Elxsi, Inc.; Pune District; On-site; INR 1,000,000 - 1,800,000; Full time

Job summary

Tata Elxsi, Inc. in Pune is seeking a Norm Compliance and Laboratory Quality Engineer to ensure product safety and regulatory compliance for MR RF coils and other hardware components.

You will assess design changes, plan IEC safety testing, and review test reports against IEC 60601-1, IEC 60601-2-33, and IEC 60601-1-2. This role also manages end-to-end laboratory activities, maintains calibration records, conducts internal audits, and ensures ISO/IEC 17025 compliance.

Qualifications

• 6 to 8 years of experience in medical device testing, compliance, calibration, or lab quality management.
• Working knowledge of ISO/IEC 17025 laboratory practices, including equipment control, calibration, record management, internal audits, and corrective-action processes.
• Hands-on experience planning or performing IEC 60601-series safety testing and preparing or reviewing the associated technical documentation.

Responsibilities

• Own end-to-end compliance testing activities from planning to report closure.
• Ensure that all lab records, calibration certificates, maintenance logs, and test documentation are maintained in an audit-ready state.
• Prepare, review, and maintain compliance with test reports, technical justifications, and support documentation in accordance with applicable standards and quality requirements.
• Drive closure of corrective and preventive actions identified during internal audits
• Coordinate with external test agencies, calibration service providers, and internal stakeholders to ensure timely completion of testing, calibration, and compliance deliverables.

Skills

Medical device testing

Regulatory compliance

Lab quality management

ISO/IEC 17025

IEC 60601-series testing

Documentation discipline

Education

B.E./B.Tech or M.E./M.Tech in Electrical/Electronics/Mechatronics/Biomedical Engineering or related

Job description

Position Title: Norm Compliance and Laboratory Quality Engineer

Overview: In this role, you will work within a multidisciplinary team to ensure product safety and regulatory compliance for MR RF coils and other hardware components. Responsibilities include assessing design changes, planning and reviewing IEC safety testing, and evaluating test reports and supporting evidence against applicable international medical-device standards and regulations, including IEC 60601-1, IEC 60601-2-33, and IEC 60601-1-2.

The role is also responsible for end-to-end laboratory management within the business unit, including maintaining test equipment and tools, controlling calibration records, conducting internal laboratory audits, and ensuring that required equipment maintenance is completed in accordance with ISO/IEC 17025.

Education:

Bachelor of Engineering or Master of Engineering in Electrical, Electronics, Mechatronics Engineering, Biomedical Engineering or a related engineering discipline.

Qualifications:

• 6 to 8 years of experience in medical device testing, compliance, calibration, or lab quality management.
• Working knowledge of ISO/IEC 17025 laboratory practices, including equipment control, calibration, record management, internal audits, and corrective-action processes.
• Hands-on experience planning or performing IEC 60601-series safety testing and preparing or reviewing the associated technical documentation.

Preferred Qualifications

• Experience coordinating with external test laboratories, calibration service providers, certification agencies, and regulatory bodies.
• Experience in medical electrical equipment, MRI systems, RF coils, or regulated healthcare product development is preferred.
• Experience conducting internal audits or working within a regulated quality management system.

Key Roles and Responsibilities:

• Own end-to-end compliance testing activities from planning to report closure.
• Ensure that all lab records, calibration certificates, maintenance logs, and test documentation are maintained in an audit-ready state.
• Prepare, review, and maintain compliance with test reports, technical justifications, and support documentation in accordance with applicable standards and quality requirements.
• Drive closure of corrective and preventive actions identified during internal audits
• Coordinate with external test agencies, calibration service providers, and internal stakeholders to ensure timely completion of testing, calibration, and compliance deliverables.

Additional Skills:

• Strong documentation discipline.
• Audit readiness mindset.
• Ability to work with cross-functional engineering teams.
• Attention to regulatory detail.
• Proactive follow-up with external vendors and calibration partners.