Jon Jagielski
Director, Life Cycle Management / NPD Quality at Edwards Lifesciences
- Role
- Director, Life Cycle Management and New Product Development Quality at Edwards Lifesciences
- Location
- Irvine, CA, US
- LinkedIn followers
- 500 followers
About Jon Jagielski
Experienced Quality and Operations Director with a demonstrated history of working in the medical device and diagnostics industries. Strong operations professional skilled in Operations Management, Supplier Quality, New Product Development, Lifecycle Management, Medical Devices, Continuous Improvement, and Leadership.
Experience
Director, Life Cycle Management and New Product Development Quality
Aug 2020 — Present · Irvine, CA, US
Leads team of Engineers as a key member of the Surgical NPD and Sustaining Quality Engineering team. Ensure that the requirements of the quality management system have been effectively documented, implemented, and maintained specific to sustaining Quality Engineering activities in-house and at Supplier sites for post-commercial release products. Work closely with suppliers, Regulatory, Clinical, and technology partners, consultants, and Global Supply Chain Team to ensure the delivery of high quality of medical devices post-launch. Identified value improvement opportunities and leads cross functional teams to improve manufacturing process technology and Post Market Surveillance metrics, using LEAN & SIX Sigma methods and lead root cause analyses to resolve complex manufacturing and compliance issues.
Education
Troy University
MS, Management
United States Naval Academy
Bachelor of Science - BS, Aerospace, Aeronautical and Astronautical/Space Engineering
Skills
- Quality System
- Continuous Improvement
- Operations Management
- Purchasing
- Process Improvement
- Product Development
- Program Management
- Business Process Improvement
- Logistics
- Medical Devices
- Leadership
- Security Clearance
- Management
- Team Leadership
- Military
- Cross-Functional Team Leadership
- Supplier Quality
- Manufacturing
- Iso 13485
- Six Sigma
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