Supplier Quality Engineer II, New Product Development

Edwards Lifesciences-posted 9 months ago
$85,000 - $120,000/Yr
Full-time • Mid Level
Fannettsburg, PA
Miscellaneous Manufacturing
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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 a critical project within the Transcatheter Heart Valve (THV) 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 part qualification efforts with external suppliers to support product development and commercial launch timelines. The Supplier Quality Engineer II will work on-site in a very fast-paced and dynamic environment where being proactive and taking initiative are paramount to success.

  • Facilitate/perform gage studies, process capability studies, and supplier process validations related to critical component features based on risks identified in FMEAs
  • Develop non-complex 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
  • Create test method procedures, and train and provide engineering support to Receiving Inspection on component test methods
  • 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
  • Provide feedback to R D and Design Assurance on supplier process output/performance and ability to measure and validate critical features on drawings
  • Bachelor's degree in Engineering or Scientific field with at least 2 years of experience with supplier quality, manufacturing, or quality engineering functions; OR Master's degree with no experience (or internship experience)
  • Highly regulated industry experience
  • Must have ability to travel up to 25%
  • Engineering degree
  • Medical Device industry experience
  • Experience with supplier quality engineering activities, including external supplier vendor audits
  • Ability to conduct effective root cause investigations; assessment of corrective action strategies; and effectiveness as applied to NCRs and SCARs
  • Proficient knowledge of Design Controls and test method development/validation
  • Experience with Class II and/or Class III medical devices
  • Knowledge of GD&T and ability to read and interpret drawings
  • Strong understanding of process validation (IQ, OQ, PQ)
  • Strong understanding with Gage R&R/measurement system analysis and process capability
  • Strong understanding of risk management principles
  • Strong understanding of manufacturing processes (i.e., injection molding, extrusion, machining, etc.)
  • Strong understanding of statistical techniques for new product development and Minitab
  • Strong understanding of Quality Management System requirements
  • Strong communication and organization skills
  • ASQ Certified Quality Engineer, Quality/Biomedical Auditor, or Six Sigma Black Belt
  • Knowledge and understanding of FDA and international regulatory standards for medical devices
  • Ability to work independently without close supervision
  • Competitive salaries
  • Performance-based incentives
  • Wide variety of benefits programs to address the diverse individual needs of employees and their families
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