Edwards Lifesciences
Manufacturing Quality Engineer II, Sustaining (2nd Shift)
USA - Utah – Salt Lake City · Mid · Internship
Sponsorship not specifiedDetected 13 days ago
Process ImprovementCustomer SupportFDA RegulatoryMedical DevicesLeadershipProblem SolvingLean Manufacturing
About the role
- Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives.
- With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs.
- Our Quality Engineer II position is a unique career opportunity that could be your next step towards an exciting future.
Responsibilities
- Manage site NCRs, CAPAs, ECRs and audit observations for all production processes prior to final product release based on engineering principles; analyze results,
- Provide technical support to external and internal audits,
- Make recommendations and develop reports.
- Oversee product release, assess and disposition product onhold (MRB), and manage material quality control.
- Optimize to optimize moderately complex Manufacturing processes using engineering methods (e.g., SIX Sigma, TOPP and LEAN methods) for design for manufacturing and for continuous process improvement.
- Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk
- Collaborate with engineering teams to ensure successful transfers
- May develop, update, and maintain technical content of risk management files, review and revise pFMEAs in conjunction with BU PMS team where applicable for the plant site.
- Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
- Process validation or support/lead TMV
Requirements
- Bachelor's degree in engineering or a scientific field with 2 years of experience in Quality Engineering, Manufacturing Engineering, Process Engineering, or related experience in a regulated manufacturing environment
- Master's degree in engineering or scientific field with no experience (or internship/co-op experience)
- Experience owning NCRs and CAPAs
- What You'll Need (Required):
- Engineering degree
- Strong understanding of MRB processes, quality metrics, and continuous improvement methodologies.
Nice to have
- What Else We Look For (Preferred):
Benefits
- Highly regulated manufacturing environment experience (medical device highly preferred)
- Proficiency with Keyence inspection systems, vision systems, or automated inspection technologies.
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