Design Quality Assurance Engineer

Job Title: Design Quality Assurance Engineer_(Immediate Joiners)
Experience: 5–8 Years
Education: B.E./B.Tech in Biomedical, Electronics, Mechanical Engineering, or a related discipline
Job Summary
We are seeking a Design Assurance Engineer to ensure that product design, risk management, verification and validation, and design-control activities comply with applicable regulatory and quality requirements throughout the product lifecycle.
Key Responsibilities
Support design control activities, including design inputs, design outputs, traceability, and maintenance of the Design History File (DHF).
Lead or support product risk-management activities, including hazard analysis, FMEA, and Risk Management File preparation.
Ensure compliance with ISO 14971 and applicable medical-device quality and regulatory requirements.
Review and approve verification and validation (V&V) protocols and reports for hardware and software.
Assess design and process changes and support Engineering Change Orders (ECOs).
Support CAPA, nonconformance, complaint, and investigation activities.
Participate in internal, customer, and regulatory audits.
Work closely with R&D, systems, software, hardware, quality, and regulatory teams.
Ensure appropriate documentation, traceability, and objective evidence are maintained throughout product development.
Required Skills
Strong knowledge of ISO 13485 and FDA 21 CFR Part 820.
Working knowledge of ISO 14971, IEC 62304, and IEC 62366.
Experience with design controls, risk management, and V&V processes.
Strong technical documentation and review skills.
Ability to interpret engineering and regulatory requirements and translate them into actionable quality processes.
Experience in audit preparation and supporting regulatory compliance activities.
Preferred
CQE, CQA, or equivalent quality certification.
Experience in medical devices or other regulated/safety-critical products.

Work arrangement
No