Design Quality Assurance Engineer

NovintiX; Hyderabad; Sur place; INR 1 200 000 - 1 800 000; Plein temps

Résumé du poste

NovintiX is seeking a Design Quality Assurance Engineer with 5–8 years of experience to ensure design controls, risk management, V&V, and regulatory compliance across the product lifecycle. The role focuses on DHF maintenance, CAPA support, audits, and collaboration with R&D, software, hardware, and regulatory teams to deliver compliant medical devices.

You will document evidence, ensure traceability, and drive adherence to ISO 13485, IEC 62304, and related standards within a fast-paced

Qualifications

• Strong knowledge of ISO 13485 and FDA 21 CFR Part 820 requirements.
• Familiar with risk management methods including FMEA and hazard analyses.
• Experience with design controls, V&V, and design history file maintenance.
• Ability to translate regulatory requirements into actionable quality processes.
• Experience in audits and regulatory compliance activities.

Responsabilités

• Support design control activities: inputs, outputs, traceability, and DHF maintenance.
• Lead or support risk management activities, including hazard analysis and FMEA.
• Ensure compliance with ISO 14971 and other applicable standards.
• Review and approve V&V protocols and reports for hardware and software.
• Assess design/process changes and support ECOs.
• Participate in internal, supplier, and regulatory audits.
• Collaborate with R&D, systems, software, hardware, and regulatory teams.
• Maintain documentation, traceability, and objective evidence throughout development.

Connaissances

ISO 13485

FDA 21 CFR 820

Risk management

V&V

Regulatory compliance

Documentation

Audit readiness

Formation

B.E./B.Tech in Biomedical, Electronics, Mechanical Eng

Description du poste

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.