NovintiX
Website:
novintix.com
Job details:
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.
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