Senior Quality Engineer, NPD/NPI

About the role

The Senior Quality Engineer, NPD/NPI oversees design quality and regulatory compliance throughout new product development for medical devices. They serve as the quality representative on cross-functional teams, guiding design control, regulatory strategies, and risk management.

Responsibilities

• Lead quality activities for new product development (NPD) and new product introduction (NPI).
• Author and review design control documentation.
• Support verification and validation processes.
• Manage nonconformances and CAPAs (Corrective and Preventive Actions).
• Prepare for audits and support post-market activities.
• Collaborate with R&D, Regulatory, Operations, and Supply Chain to ensure quality integration.

Requirements

• Bachelor’s degree in Engineering or a related field.
• 6+ years of medical device quality experience.
• Knowledge of FDA (21 CFR Part 820) and ISO (13485) standards.

Preferred Qualifications

• Experience supporting Class II/III medical devices.
• Experience with FDA submissions and audits.
• Familiarity with standards such as IEC 60601.

Skills

• Strong communication and problem-solving abilities.
• Ability to manage tasks independently.