Design Quality Engineer

Hiring:
Design Quality Engineer – Medical Devices

We are looking for an experienced Design Quality Engineer to join our Medical Device team. The ideal candidate will have a strong understanding of design controls, product development, quality systems, and regulatory compliance while supporting the development and commercialization of innovative medical devices.

Location: NJ, Onsite, USA

• Support product development activities from concept through commercialization.
• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and applicable regulatory requirements.
• Lead Design Control activities including Design Reviews, Design Verification, Design Validation, and Design Transfer.
• Develop and maintain Design History Files (DHF), Device Master Records (DMR), and technical documentation.
• Perform risk management activities in accordance with ISO 14971, including DFMEA and risk assessments.
• Review Engineering Change Orders (ECOs) and assess product quality impact.
• Support CAPA, nonconformance investigations, and root cause analysis.
• Partner with R&D, Manufacturing, Regulatory Affairs, and Operations to ensure product quality throughout the product lifecycle.
• Participate in internal and external quality audits.

• Bachelor's degree in Engineering or a related technical discipline.
• 5+ years of Design Quality Engineering experience within the Medical Device industry.
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, Design Controls, and ISO 14971.
• Experience with Design Verification and Validation activities.
• Excellent communication, documentation, and problem-solving skills.
• ASQ Certified Quality Engineer (CQE) certification is a plus.

• Experience with Class II or Class III Medical Devices.
• Knowledge of product development and New Product Introduction (NPI).
• Familiarity with CAPA, NCR, FMEA, and Root Cause Analysis.