Supplier Quality Engineer II, Component New Product Development

Edwards Lifesciences • Irvine, CA

1d • $87,000 - $123,000 • Onsite

About The Position

The Supplier Quality Engineer II supports critical projects within the Surgical business unit, working cross-functionally with R&D, Design Assurance, Operations, Regulatory Affairs, Supplier Development Engineering, and Receiving Inspection. The primary focus is leading parts qualification efforts with external suppliers to support product development and commercial launch timelines. The role also addresses manufacturing quality issues; supports CAPA and non-conformance activities; validates and improves processes; manages risk documentation; and drives Lean/Six Sigma improvements while ensuring regulatory and quality-system compliance. This position is performed fully on-site in a fast-paced, dynamic environment that calls for initiative and proactive problem solving.

The role includes supplier qualification and validation work, test method development, support for design documentation and Receiving Inspection, supplier audits, and management of supplier-related non-conformances and corrective action requests. The engineer reports supplier part qualification status at recurring cross-functional project meetings.

Requirements

• Bachelor’s degree in an engineering or scientific field and at least 2 years of experience in supplier quality, quality, manufacturing, or production engineering activities; alternatively, a master’s degree with no experience, including internship/co-op experience.
• Experience in a highly regulated industry.
• Ability to travel up to 15%–20%.
• Willingness and ability to work on-site 100%.

Nice To Haves

• Engineering degree.
• Medical Device, Aerospace, or Automotive industry experience.
• Experience and/or proficient knowledge of Design Controls and test method development/validations.
• Experience with statistical techniques and tools such as Gage R&R, Statistical Process Control, or Process Capability Studies.
• Ability to conduct effective root cause analysis, drive non-conformance investigations, and assess corrective action strategies and effectiveness as applied through CAPAs.
• Knowledge of GD&T and ability to read and interpret drawings.
• Good understanding of process validations (IQ, OQ, PQ).
• Good understanding of manufacturing processes such as injection molding, extrusion, and machining.

Responsibilities

• Facilitate or perform gage studies, process capability studies, and supplier process validations for critical component features based on risks identified in FMEAs.
• Develop and validate test methods, including creating inspection routines on optical measurement equipment and designing and creating inspection fixtures using SolidWorks.
• Manage component and supplier qualification activities from initiation through closure.
• Support completion of Design File requirements for supplied components, subassemblies, devices, and services.
• Create test method procedures and provide training.
• Provide engineering support to Receiving Inspection on component test methods and investigations.
• Conduct on-site supplier audits.
• Manage supplier-related non-conformances.
• Manage supplier corrective action requests from initiation through closure.
• Report supplier part qualification status at recurring cross-functional project meetings.
• Resolve manufacturing quality issues, support CAPA and non-conformance activities, validate and improve processes, manage risk documentation, and drive Lean/Six Sigma improvements while ensuring regulatory and quality-system compliance.

Benefits

• Competitive salaries.
• Performance-based incentives.
• A wide variety of benefits programs to address the diverse individual needs of employees and their families.

What This Job Offers

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