Principal Quality Engineer, Receiving & Inspection

Edwards Lifesciences • Irvine, CA

9h

About The Position

Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology. We are seeking a Principal Quality Engineer to join our Receiving & Inspection organization, playing a critical role in ensuring product quality, regulatory compliance, and successful product transfers from New Product Development (NPD) into manufacturing. This highly visible role requires a hands-on technical leader who can evaluate inspection readiness, apply statistical rigor to decision-making, and partner cross-functionally with Manufacturing, Regulatory Affairs, Supplier Quality, NPI/NPD, and Advanced Quality Engineering teams. The ideal candidate will bring strong expertise in inspection methodologies, statistical analysis, and quality systems, combined with the ability to influence stakeholders, challenge assumptions, and drive robust, inspection-ready processes across sites.

Requirements

• Bachelor’s degree within engineering or scientific fields, plus at least 6 years of relevant experience; OR Master’s degree within engineering or scientific fields, plus at least 5 years of relevant experience.
• Statistical analysis experience (i.e. T-tests, Gage R&R), or similar statistical methods
• Proven project management experience, including leading cross-functional teams and driving projects from initiation through completion
• Strong knowledge of test method validation and equipment/process qualifications (IQ/OQ/PQ)
• Experience working within a highly regulated industry

Nice To Haves

• Engineering degree
• Experience supporting product transfers (NPD > manufacturing), including inspection readiness and quality planning
• Ability to read and interpret engineering drawings, including knowledge of GD&T
• Experience designing or working with inspection fixtures and tooling
• Familiarity with vision inspection systems (e.g., Keyence, SmartScope)
• Hands-on experience with inspection processes, metrology tools, and quality systems
• Experience managing NCRs, CAPAs, and root cause investigations
• Experience partnering with or supporting Regulatory Affairs in quality or submission-related activities
• Demonstrated ability to influence stakeholders and drive decisions in a cross-functional environment
• Strong resilience and ability to operate effectively in a high-accountability, fast-paced environment
• Certified Quality Engineer (CQE) or equivalent certification

Responsibilities

• Lead inspection readiness and product transfer activities from NPD to manufacturing for complex medical devices, ensuring alignment with internal procedures and regulatory requirements
• Evaluate and approve inspection plans, providing critical feedback based on practical, on-the-floor understanding of manufacturing and inspection processes
• Apply advanced statistical analysis (e.g., T-tests, Gage R&R) to assess process capability, support decision-making, and justify quality and inspection strategies
• Partner with cross-functional teams (i.e. Manufacturing, Regulatory Affairs, etc.) to optimize sampling plans and inspection strategies, including justification for reduced sampling where appropriate
• Serve as a technical lead on cross-functional projects, driving initiatives from concept through execution with a strong project management mindset
• Manage and support NCR and CAPA activities, including leading investigations and ensuring effective resolution and closure
• Conduct root cause analysis using structured methodologies (e.g., Fishbone/Ishikawa), and author clear, data-driven investigation reports
• Drive preventive action strategies and ensure alignment of quality practices across multiple sites
• Provide hands-on technical support, including inspection execution, measurement techniques, and tool usage (e.g., calipers and metrology equipment)
• Collaborate with global teams to ensure consistent quality standards and scalable inspection processes
• Perform other incidental duties as required to support the overall objectives of the department and organization.

Benefits

• competitive salaries
• performance-based incentives
• a wide variety of benefits programs to address the diverse individual needs of our employees and their families

What This Job Offers

• Job Type: Full-time
• Career Level: Principal