Edwards Lifesciences
Principal Supplier Quality Engineer, New Product Development
USA - Utah – Salt Lake City · Principal
Sponsorship not specifiedDetected 7 days ago
A/B TestingProject ManagementProcess ImprovementVendor ManagementFDA RegulatoryMedical DevicesLeadershipCollaborationProblem SolvingMentoringRegulatory Affairs
About the role
- 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.
- Your work will involve you optimizing product development to impact patients around the world with pioneering technology.
Requirements
- Imagine how your ideas and expertise can change a patient's life.
- Bachelor's degree with 6 years of experience in either Supplier Quality, Manufacturing, New Product Development/Improvement, or Quality Engineering functions
- OR Master's degree with 5 years of experience in either Supplier Quality, Manufacturing, New Product Development/Improvement, or Quality Engineering functions
Nice to have
- Engineering degree
- Experience with supplier/vendor management and qualification activities with new suppliers, CMOs (Contract Manufacturing Organizations), or OEMs for new products.
- Experience with CAPAs, NCRs, Change Notifications, and/or Auditing.
- Demonstrated experience driving component testing, test method validations, and testing/validating equipment.
- In-depth understanding and experience with risk management for validation qualifications (e.g. equipment or process OQ/PQs).
- In-depth knowledge of manufacturing process for shaft manufacturing, injection molding and extrusions.
- Six Sigma Green or Black Belt Certified.
Skills
- Develop technical content of risk management files.
- Conduct on-site supplier audits.
- Provide training, coaching, and mentorship to engineers on Supplier Quality procedures and responsibilities.
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