Supplier Quality Engineer II, Component New Product Development
Edwards Lifesciences
Summary
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.
Job description
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.).
Requirements
- 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%
- 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.)
Benefits
- Competitive Salaries
- Performance-Based Incentives
- Wide Variety of Benefits Programs
Company overview
Edwards Lifesciences (NYSE: EW) is the leading global structural heart innovation company, driven by a passion to improve patient lives. Founded in 1958 and headquartered in Irvine, California, the company specializes in developing breakthrough technologies for cardiovascular diseases. As a pioneer in the medical device industry, Edwards focuses on transcatheter heart valves, surgical heart valves, hemodynamic monitoring systems, and vascular solutions. The company's patient-focused culture inspires its 16,000+ employees worldwide to deliver life-changing innovations that address complex heart health challenges. Edwards serves patients in over 100 countries through its comprehensive portfolio of products including the SAPIEN transcatheter heart valve system, INSPIRIS surgical valves, and advanced monitoring technologies. With a commitment to research and development, the company invests 17-18% of its revenue back into R&D efforts, maintaining its position at the forefront of structural heart innovation. Edwards Lifesciences has impacted over one million patients globally through its transformative medical technologies.