Principal Quality Engineer - Catheters & Extrusions

Edwards; Irvine (CA); On-site; USD 121,000 - 171,000; Full time

Job summary

Edwards is seeking a Principal Quality Engineer to act as a technical QA expert supporting Advanced Catheters and Extrusions from early development through commercialization. You will partner with R&D, Process Engineering, Manufacturing, Operations and other Quality teams across sites to provide leadership on validation, testing, and risk management.

The role requires a strong background in Test Method Validation, IQ/OQ/PQ, and experience in a highly regulated medical device environment.

Qualifications

• Bachelor's or Master's in engineering/science with related experience in quality
• Experience with Test Method Validation and process/equipment validation (IQ/OQ/PQ)
• Highly regulated industry experience required

Responsibilities

• Serve as QA SME for Advanced Catheters and Extrusions from development to commercialization.
• Lead QA activities supporting development, validation of products, processes, equipment and test methods.
• Apply data-driven approach to capability studies, data analysis and risk assessment for products and processes.
• Provide QA expertise for extrusion, polymer, catheter, and balloon technologies, including material properties and tolerances.
• Collaborate across R&D, Process Engineering, Manufacturing, Operations, and Supplier Quality to ensure robust products.
• Support manufacturing readiness, technology transfer, and commercialization across sites.
• Develop and approve validation protocols, reports, specifications and risk management documentation.
• Lead investigations, CAPAs, and supplier quality issues as needed.
• Mentor engineers and technicians to build QA capability across programs.

Skills

Quality Engineering

Process Engineering

Statistical analysis

CAPA

IQ/OQ/PQ

Education

Bachelor's degree in engineering or scientific related fields

Master's degree in engineering or scientific related fields

Tools

TMV

IQ/OQ/PQ

Job description

Edwards is seeking a Principal Quality Engineer to act as a technical QA expert supporting Advanced Catheters and Extrusions from early development through commercialization. You will partner with R&D, Process Engineering, Manufacturing, Operations and other Quality teams across sites to provide leadership on validation, testing, and risk management.

The role requires a strong background in Test Method Validation, IQ/OQ/PQ, and experience in a highly regulated medical device environment.