Supplier Quality Engineer II, Component New Product Development

Regulatory Toolkit; Irvine (CA); On-site; USD 87,000 - 123,000; Full time

Job summary

Edwards Lifesciences in Irvine, CA, seeks a Supplier Quality Engineer II to lead critical supplier qualification efforts supporting medical device product development and launches. You will collaborate with R&D, Design Assurance, Operations and Regulatory Affairs to ensure quality systems and risk management align with strict regulatory requirements.

Requires a Bachelor’s in engineering or science and 2+ years in supplier quality or manufacturing in a highly regulated environment, with up to 20%

Qualifications

• Bachelor’s degree in engineering or scientific field; highly regulated industry experience.
• Willing to travel up to 15–20%; onsite 100% in Irvine, CA.

Responsibilities

• Facilitate/perform gage studies, process capability studies, and supplier process validations.
• Develop and validate test methods, inspection routines and fixtures (SolidWorks).
• Manage component and supplier qualification from initiation to closure.
• Support Design File requirements for supplied components, subassemblies, devices, and services.
• Create test method procedures and provide training; support Receiving Inspection on test methods and investigations.
• Conduct on-site supplier audits.
• Manage supplier-related non-conformances.
• Manage supplier corrective action requests from initiation to closure.
• Report supplier qualification status at cross-functional project meetings.

Education

Bachelor's degree in engineering or scientific field

Master’s degree

Tools

Gage R&R

Statistical Process Control

Process Capability Studies

GD&T

Job description

Imagine how your ideas and expertise can change a patient’s life. 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.

The Supplier Quality Engineer II will play a key role on critical projects within the Surgical business unit. This position is cross-functional in nature and requires strong collaboration and partnership with R&D, Design Assurance, Operations, Regulatory Affairs, Supplier Development Engineering and Receiving Inspection. The primary focus of the position is leading successful parts qualification efforts with external suppliers to support product development and commercial launch timelines. Will also be responsible for resolving manufacturing quality issues, supporting CAPA/non-conformances, validating and improving processes, managing risk documentation, and driving Lean/Six Sigma improvements while ensuring regulatory and quality-system compliance. This role will work on-site in a very fast-paced and dynamic environment where being proactive and taking initiative is paramount to success.

How you will make an impact:

• Facilitate/perform gage studies, process capability studies, and supplier process validations related to critical component features based on risks identified in FMEAs.
• Develop and validate test methods, which can encompass creating inspection routines on optical measurement equipment and design and creation of inspection fixtures using SolidWorks.
• Manage component and supplier qualification activities from initiation to closure.
• Supports completion of Design File requirements applicable to 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 to closure.
• Report on supplier part qualification status at recurring cross-functional project meetings

What you’ll need (Required):

• Bachelor’s degree in engineering or scientific field with at least 2 years of experience with either supplier quality, quality, manufacturing, or production engineering activities; OR Master’s degree with no experience (or internship/co-op experience).
• Highly regulated industry experience.
• Must have ability to travel up to 15% - 20%.
• Must be willing and able to work onsite 100%.

What else we look for (Preferred):

• 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; driving non-conformance investigations; and assessment of 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 (i.e., injection molding, extrusion, machining, etc.).

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California, the base pay range for this position is $87,000 - $123,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.