Design Quality Assurance Engineer

NovintiX; Hyderabad; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

NovintiX in Hyderabad is seeking a Design Quality Assurance Engineer (Immediate Joiners) to ensure design controls, risk management, V&V, and design-history-file activities meet regulatory requirements.

The role collaborates with R&D, software, hardware, and quality teams to maintain documentation, traceability, and evidence throughout product development, and to support audits and CAPA as needed.

Qualifications

• Experience implementing design controls and maintaining the DHF.
• Knowledge of ISO 13485 and regulatory requirements.
• Audits preparation and regulatory support experience.
• Strong documentation and review skills.
• Ability to translate regulatory requirements into actionable quality processes.

Responsibilities

• Support design control activities, including DHF maintenance.
• Lead or support risk management activities including hazard analysis and FMEA.
• Ensure ISO 14971 and FDA 21 CFR Part 820 compliance.
• Review V&V protocols and reports for hardware and software.
• Assess design and process changes; support ECOs.
• Support CAPA, nonconformance, and investigations.
• Participate in internal, supplier, and regulatory audits.
• Collaborate with R&D, systems, software, hardware, quality, and regulatory teams.
• Maintain documentation, traceability, and objective evidence throughout development.

Skills

ISO 13485

FDA 21 CFR Part 820

ISO 14971

IEC 62304

IEC 62366

Design controls

Risk management

V&V processes

Technical documentation

Regulatory compliance

Education

B.E./B.Tech in Biomedical, Electronics, Mechanical Engineering, or related discipline

Job description

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.