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.
- Solid 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.

📌 Design Quality Assurance Engineer (Hyderabad)
🏢 NovintiX
📍 Hyderabad