Senior Quality Assurance Engineer – Medical Devices Position

Designation: Senior Quality Assurance Engineer

Function: Quality Assurance / Quality Engineering

Industry: Medical Devices

Experience: 7+ Years

Education: B.E./B.Tech in Electronics & Communication, Electrical & Electronics, Electrical Engineering, Mechanical Engineering, Biomedical Engineering, or a related engineering discipline.

Job Summary

We are seeking an experienced Senior Quality Assurance Engineer to lead and support Quality Assurance activities across the medical device product lifecycle. The role will be responsible for maintaining and continuously improving the Quality Management System, ensuring product and process compliance, managing risk, CAPA and non-conformances, supporting supplier and manufacturing quality, and ensuring compliance with applicable global medical device regulations and standards.

The successful candidate will work closely with R&D;, Manufacturing, Regulatory Affairs, Service, Supply Chain and other cross-functional teams to ensure product quality, patient safety, regulatory compliance and continual improvement.

Key Responsibilities1. Quality Management System

- Implement, maintain and continuously improve the Quality Management System in accordance with ISO 13485:2016.
- Develop, review and maintain SOPs, Work Instructions, forms and quality records.
- Maintain and control Device Master Records (DMR), Device History Records (DHR) and other applicable quality documentation.
- Ensure effective implementation of documented procedures and quality processes.

1. Product Quality Assurance

- Ensure quality compliance throughout the product lifecycle, from design and development through manufacturing, inspection, testing, final release and post-market activities.
- Review product and process documentation for compliance with approved specifications and procedures.
- Support design transfer and production readiness activities.
- Monitor product-quality trends and identify opportunities for improvement.

1. Risk Management

- Develop, review and maintain product Risk Management Files in accordance with ISO 14971:2019.
- Perform and review Hazard Analysis, FMEA and risk evaluations.
- Ensure appropriate implementation and verification of risk-control measures.
- Assess the impact of product, process and design changes on product risk.
- Support risk-benefit analysis and overall residual-risk evaluation where applicable.

1. CAPA and Non-Conformance Management

- Lead and manage NCR, CAPA and root-cause investigations.
- Apply structured root-cause analysis techniques such as 5-Why, Fishbone/Ishikawa and other appropriate problem-solving methodologies.
- Define corrective and preventive actions and establish appropriate implementation timelines.
- Verify CAPA effectiveness and ensure timely closure.
- Monitor recurring issues and quality trends to prevent recurrence.

1. Complaint and Post-Market Surveillance

- Support investigation, documentation and closure of customer complaints and field failures.
- Coordinate with relevant technical, manufacturing, service and regulatory teams during complaint investigations.
- Perform complaint trending and identify recurring product or process issues.
- Support appropriate corrective actions and post-market quality activities.

1.



Manufacturing Quality

- Monitor manufacturing processes to ensure conformity with approved specifications and procedures.
- Develop and review PFMEA, Control Plans, inspection criteria and quality checkpoints.
- Establish appropriate in-process and final inspection controls.
- Support process validation and process improvement activities where applicable.
- Investigate manufacturing-related quality issues and implement corrective actions.

1. Testing and Inspection

- Plan, coordinate and review incoming, in-process, final-product and functional testing activities.
- Ensure testing is performed against approved specifications, protocols, procedures and acceptance criteria.
- Support electrical, performance, safety and product-specific testing requirements.
- Review test results, deviations and failures and support appropriate investigation and disposition.
- Ensure inspection and test equipment is appropriately controlled and calibrated.

1. Supplier Quality

- Support qualification, evaluation and ongoing monitoring of critical suppliers and manufacturing partners.
- Conduct or support supplier quality audits.
- Monitor supplier performance and quality metrics.
- Manage supplier-related non-conformances and SCAR/SCIA activities.
- Review supplier corrective actions and verify effectiveness.
- Support supplier process and change assessments.

1. Change Control

- Review product, process, supplier, manufacturing and engineering changes.
- Perform quality, risk and regulatory impact assessments.
- Determine appropriate verification, validation and documentation requirements for changes.
- Ensure changes are implemented through the approved Change Control process.
- Assess the impact of changes on regulatory submissions, product risk and existing quality documentation.

1. Regulatory Compliance

- Support compliance with applicable global medical-device regulatory requirements.
- Support regulatory submissions, technical documentation, product registrations and certification activities.
- Maintain awareness of applicable requirements including:
- EU MDR 2017/745 / MDD 93/42/EEC
- US FDA medical-device requirements
- CDSCO Medical Device Rules, 2017
- UKCA / MHRA requirements
- Other applicable international regulatory requirements.
- Support regulatory change assessments and implementation of new or revised requirements.

1. Audit and Inspection Support

- Lead or support internal, supplier, Certification Body, Notified Body and regulatory audits.
- Prepare audit documentation and coordinate responses to audit findings.
- Support root-cause analysis and corrective actions for audit observations and non-conformities.
- Track audit actions through effective and timely closure.
- Promote audit readiness and a culture of compliance across the organization.

1. Continuous Improvement

- Analyze quality data, KPIs and trends to identify improvement opportunities.




- Drive initiatives to reduce defects, complaints, rework, NCRs and recurring quality issues.
- Support Lean, Six Sigma, problem-solving and process-improvement initiatives where applicable.
- Develop and monitor quality metrics and management reports.

1. Cross-Functional Collaboration

- Work closely with R&D;, Production, Regulatory Affairs, Service, Supply Chain and other functional teams.
- Provide quality inputs during product development, design transfer, manufacturing and post-market activities.
- Provide guidance on quality and regulatory requirements to cross-functional teams.
- Promote a solid culture of product quality, patient safety and regulatory compliance.

Key Standards and Regulations The candidate should have practical working knowledge of:
- ISO 13485:2016 – Medical Device Quality Management Systems
- ISO 14971:2019 – Medical Device Risk Management
- IEC 60601 Series – Medical Electrical Equipment
- IEC 62304 – Medical Device Software Life Cycle Processes
- IEC 62366-1 – Medical Device Usability Engineering
- ISO 15223-1 – Medical Device Symbols for Labelling
- EU MDR 2017/745 / MDD 93/42/EEC
- CDSCO Medical Device Rules, 2017
- US FDA medical-device quality and regulatory requirements
- UKCA / MHRA requirements

Required Skills and Competencies
- Strong knowledge of Medical Device Quality Assurance and Quality Engineering.
- Hands-on experience with ISO 13485 and ISO 14971.
- Strong understanding of CAPA, NCR, complaint handling and root-cause analysis.
- Experience with FMEA/PFMEA, Control Plans and risk-management documentation.
- Knowledge of medical-device manufacturing, inspection and testing processes.
- Experience in supplier quality management and supplier audits.
- Strong understanding of Change Control and quality impact assessment.
- Experience supporting internal and external audits.
- Good understanding of medical-device regulatory requirements.
- Strong analytical, problem-solving and documentation skills.
- Ability to work effectively with cross-functional and multidisciplinary teams.
- Strong communication, coordination and stakeholder-management skills.

Educational Qualification
- B.E./B.Tech in:
- Electronics & Communication Engineering
- Electrical & Electronics Engineering
- Electrical Engineering
- Mechanical Engineering
- Biomedical Engineering
- or a related engineering discipline.

Experience
- 7+ years of relevant experience in Medical Device Quality Assurance, Quality Engineering or a closely related function.
- Demonstrated experience working with medical-device QMS, product quality, risk management, CAPA/NCR, manufacturing quality and audits.
- Experience with regulated medical-device products and applicable international standards is preferred.

Key Performance Areas
- QMS compliance and continual improvement
- Product and process quality
- CAPA and NCR effectiveness
- Risk-management compliance
- Complaint and post-market quality
- Supplier quality performance
- Audit readiness and closure
- Regulatory compliance
- Reduction of recurring quality issues
- Timely completion of quality deliverables
- Patient safety and product conformity

Preference For Immediate Joiner Pay: ₹25,000.00 - ₹40,000.00 per month

Work Location: In person

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