About the role
This role focuses on ensuring product quality and regulatory compliance within the medical device or automotive industry. Key areas include Design Quality Assurance, Post-Market Surveillance, and Complaint Management. The position requires deep expertise in risk management methodologies, process verification and validation, and adherence to Quality Management Systems standards such as ISO 13485, ISO 14971, EU MDR, and 21 CFR 820.
Responsibilities
- Develop procedures for process control, improvement, testing, and inspection; design sophisticated testing equipment and analyze results to minimize defects.
- Review QA documentation for product sustenance, regulatory submissions, and New Product Introduction (NPI); execute risk management and define design verification/validation requirements.
- Analyze quality reports and defective products to identify trends, determine root causes, and implement corrective actions (CAPA).
- Partner with R&D, Regulatory, Clinical, and suppliers to resolve quality problems, implement effective corrective actions, and drive continuous improvement.
- Manage Change Requests for technical documentation (IFU/IFP) and maintain compliance with Quality Management Systems (ISO 13485, ISO 14971, EU MDR, 21 CFR 820).
Full description
Job Description-
Quality Engineer support project.
Project Summary (Support requirement)
We are seeking an experienced Quality Assurance Engineer to oversee Design Quality, Post-Market Surveillance, and Complaint Management. This independent contributor role focuses on ensuring product excellence, regulatory compliance, and robust risk management throughout the product lifecycle.
Key Responsibilities
Design Quality Assurance
Process Control & Testing: Develop procedures for process control, improvement, testing, and inspection; design sophisticated testing equipment and analyze results to minimize defects.
Product Development & NPI: Review QA documentation for product sustenance, regulatory submissions, and New Product Introduction (NPI); execute risk management and define design verification/validation requirements.
Design Reviews: Participate in design reviews to identify product risks and ensure manufacturing processes and documentation mitigate these issues.
Post-Market & Complaints
Trend Analysis: Analyze quality reports and defective products to identify trends, determine root causes, and implement corrective actions (CAPA).
Cross-Functional Collaboration: Partner with R&D, Regulatory, Clinical, and suppliers to resolve quality problems, implement effective corrective actions, and drive continuous improvement.
Documentation & Standards: Manage Change Requests for technical documentation (IFU/IFP) and maintain compliance with Quality Management Systems (ISO 13485, ISO 14971, EU MDR, 21 CFR 820).
Job Requirements
Education: B.Tech in Mechanical or Biomedical Engineering (or equivalent practical knowledge).
Experience: 4–6 years of experience in Quality Assurance within the Medical Device or Automotive industry.
Domain Expertise: Strong background in Design Quality, Risk Management methodologies, and process verification/validation.
Technical Knowledge: Familiarity with QMS standards (ISO 13485, 21 CFR 820), CAPA, statistics, and the ability to interpret CAD drawings (optional).
Certifications: ASQ Certified Quality Engineer, Certified Six Sigma Green Belt, or Certified Quality Auditor preferred.