Design Quality Engineer – Medical Devices & Regulatory

HCL Technologies Limited; Raritan (NJ); On-site; USD 69,000 - 77,000; Full time

Benefits offered by this job

Medical insurance

Dental/Vision coverage

401(k) retirement plan

Paid time off ( PTO )

Job summary

HCLTech is seeking a Design Quality Engineer to advance medical device development with emphasis on design controls, risk management, and regulatory compliance. This role requires hands-on experience in design and development, and leads documentation and regulatory activities in a fast-paced environment.

The candidate will participate in CAPA investigations, review DHF deliverables, and ensure adherence to ISO 13485, FDA 21 CFR Part 820, EU MDR, and ISO 14971.

Qualifications

• Hands-on experience in medical device design and development.
• Experience with FDA-regulated Design Controls, Change Controls, and NPD.
• Lead and maintain Risk Management Files including Hazard Analysis and FMEAs.
• Review and approve DHF deliverables and quality documentation.
• Review and approve verification, validation, and design transfer deliverables.

Responsibilities

• Participate in CAPA and nonconformance investigations.
• Analyze quality metrics and complaint trends to drive improvement.
• Serve as a Design Quality SME during audits and inspections.
• Review Component Qualification, IQ, OQ, PQ, TMV, and Gage R&R studies.
• Assess product and supplier changes for quality/regulatory impact.

Skills

Design Controls

Quality Assurance

Education

BE/M.Tech in Mechanical Engineering

Tools

IQ/OQ/PQ

TMV

MSA

Job description

HCLTech is seeking a Design Quality Engineer to advance medical device development with emphasis on design controls, risk management, and regulatory compliance. This role requires hands-on experience in design and development, and leads documentation and regulatory activities in a fast-paced environment.

The candidate will participate in CAPA investigations, review DHF deliverables, and ensure adherence to ISO 13485, FDA 21 CFR Part 820, EU MDR, and ISO 14971.