Jeffrey Rufner
Staff Engineer Process Validation at Zimmer Biomet
- Role
- Staff Engineer Process Validation at Zimmer Biomet
- Location
- Indianapolis, IN, US
- LinkedIn followers
- 500 followers
About Jeffrey Rufner
To provide help to companies in the regulated medical device space for complex testing…
Experience
Staff Engineer Process Validation
Aug 2018 — Present · Warsaw, IN, US
Working in an operations support role for this medical device leader in the area of cleanliness, water systems, biological upgrade, and other end of line activities.Author and maintain global cleanliness documentation as well as represent firm in ISO and ASTM efforts for standards in this area. Currently technical contact for an effort at ASTM to provide guidance to industry for establishment of cleanliness limits for medical devices. Support supplier quality and transfer teams in training outside suppliers as well as internal employees in validation methodology and cleaning topics.
Education
Indiana Wesleyan University
Master's degree, MBA
Indiana University Bloomington
Bachelor of Arts (B.A.)
Skills
- Management
- Design of Experiments
- Manufacturing
- R&D
- Medical Devices
- Capa
- Laboratory
- Team Leadership
- Iso 13485
- Sop
- Orthopedics
- Fda
- Quality System
- V&V
- Polymers
- Biomedical Engineering
- Product Development
- Corrective and Preventive Action (Capa)
- U.s. Food and Drug Administration (Fda)
- Testing
- Validation
- Cross-Functional Team Leadership
- Biomaterials
- Supplier Quality
- Orthopedic
- Quality Auditing
- Leadership Development
- Root Cause Analysis
- Calibration
- Quality Control
- Research and Development (R&D)
- Change Control
- Coaching
- U.s. Title 21 Cfr Part 11 Regulation
- 21 Cfr Part 11
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