Principal Device Quality Engineer

Key Responsibilities:

• Serve as Global Process Owner for CAPA subsystem, ensuring compliance with FDA, ISO, and EU MDR requirements.
• Facilitate CAPA Review Board and lead complex investigations using root cause analysis tools.
• Monitor CAPA performance through KPIs and drive systemic improvements.

Required Skills:

• Deep knowledge of 21 CFR Part 820, ISO 13485, ISO 14971, and EU MDR.
• Statistical competence with tools like Tableau, Minitab.
• Strategic thinking and ability to influence without authority.

Education & Experience:

• Bachelor’s degree in Engineering or related Life Science.
• 8+ years of Quality Engineering experience in Medical Devices with CAPA expertise.
• Experience interacting with regulatory bodies during inspections.

What We Offer:

• Base salary range $150,858 to $155,000 per year.
• Cash bonus and equity.
• Opportunity to work in a cutting-edge medical technology company.