SaMD Design Quality Engineer

Tata Elxsi, Inc.; Pune District; On-site; INR 1,200,000 - 2,100,000; Full time

Job summary

Tata Elxsi, Inc. seeks a quality and regulatory affairs professional to oversee SaMD product development, ensure compliance with EU MDR, ISO 13485, ISO 14971, and related standards, and support audits and QMS processes.

Role involves maintaining risk management and design controls, supporting DHF documentation, and coordinating audits with internal teams across the lifecycle.

Qualifications

• Bachelor's degree in a relevant discipline or equivalent experience.
• 3 to 8 years of regulated industry experience; medical device and SaMD preferred.
• Strong knowledge of EU MDR 2017/745, ISO 13485, ISO 14971, IEC 62304, IEC 82304, IEC 81001-5-1, FDA QMS/21 CFR 11 & 820.
• Working knowledge of software development lifecycles, Agile methodologies, and design controls in software.
• Experience participating in regulatory, certification, or quality system audits is desirable.
• Excellent written and verbal communication with ability to create compliant quality records.

Responsibilities

• Provide quality oversight for SaMD product development, design controls, software lifecycle activities.
• Review and maintain traceability between user needs, requirements, risk controls, test cases, and results.
• Support Design History File (DHF) and technical documentation to ensure audit readiness.
• Facilitate ISO 14971 risk management activities, including hazard analysis, risk evaluation, control implementation, residual risk assessment, and cybersecurity reviews.
• Maintain Risk Management Files and ensure risk updates throughout the product lifecycle.
• Own or support key QMS processes including CAPA, complaint handling, nonconformance management, document control, and continuous improvement activities.
• Conduct investigations, root cause analysis, effectiveness checks, and compliance assessments within required timelines.
• Support internal audits, regulatory inspections, and external audits (FDA, Notified Body, MDSAP, ISO 13485).
• Perform gap assessments and integration activities for acquired products, QMS processes, and design documentation.
• Act as the quality representative for assigned product teams, provide compliance guidance, and escalate quality risks when required.

Skills

Regulatory knowledge

Documentation

Audits coordination

Software lifecycle understanding

Education

Bachelor's degree in a relevant discipline

Job description

Roles & Responsibilities

Provide quality oversight for SaMD product development, design controls, software lifecycle activities, verification/validation, release, and design transfer.

Review and maintain traceability between user needs, requirements, risk controls, test cases, and results.

Support Design History File (DHF) and technical documentation to ensure audit readiness.

Facilitate ISO 14971 risk management activities, including hazard analysis, risk evaluation, control implementation, residual risk assessment, and cybersecurity reviews.

Maintain Risk Management Files and ensure risk updates throughout the product lifecycle.

Own or support key QMS processes including CAPA, complaint handling, nonconformance management, document control, and continuous improvement activities.

Conduct investigations, root cause analysis, effectiveness checks, and compliance assessments within required timelines.

Support internal audits, regulatory inspections, and external audits (FDA, Notified Body, MDSAP, ISO 13485).

Perform gap assessments and integration activities for acquired products, QMS processes, and design documentation.

Act as the quality representative for assigned product teams, provide compliance guidance, and escal quality risks when required.

Minimum Qualifications, Education & Experience

Bachelor's degree in a relevant discipline or equivalent experience.

3 to 8 years of experience in a regulated industry; medical device and SaMD experience preferred.

Strong knowledge of EU MDR 2017/745, ISO 13485, ISO 14971, IEC 62304, IEC 82304, IEC 81001-5-1, FDA Quality System/Quality Management System requirements, 21 CFR Part 11, and 21 CFR Part 820.

Working knowledge of software development lifecycles, Agile methodologies, and application of design controls within software development.

Experience participating in regulatory, certification, or quality system audits is desirable.

Excellent written and verbal communication skills with the ability to create clear, compliant, and defensible quality records.

Strong attention to detail, organizational skills, and ability to manage multiple priorities.