Principal Quality Assurance Engineer

About the role

The Principal Quality Assurance Engineer will lead the full design control process for medical devices, from validating design inputs through verification, validation and design transfer, ensuring compliance with quality and regulatory standards.

Key responsibilities

• Plan and execute comprehensive process validation strategies using statistical tools to transition new products to production.
• Lead design control activities, including eliciting and validating design inputs, managing verification, validation and design transfer.
• Conduct root cause analysis, manage CAPA processes and drive continuous improvement across the product lifecycle.
• Guide risk management throughout the product lifecycle, identifying, assessing and mitigating potential risks.

Required profile

• Bachelor’s or Master’s degree in Mechanical Engineering, Electronics Engineering, Science or equivalent.
• 5+ years of experience in medical device design quality assurance, risk management or related fields; 8+ years preferred.

What we offer

• Salary range $120,000 – $170,400 annually.
• Comprehensive benefits including generous PTO, 401(k) with up to 7% match, HSA contributions, stock purchase plan and education reimbursement.
• Opportunity to work at Philips, a global health technology leader focused on improving lives.