Carla Konzel
Regulatory Affairs, Senior Manager at STERIS
- Role
- Regulatory Affairs, Senior Manager at STERIS
- Location
- Erie, PA, US
- LinkedIn followers
- 500 followers
About Carla Konzel
Dynamic and results-driven Regulatory Affairs professional with proven expertise in Quality and Regulatory Compliance, Certificate Management, and collaboration with Notified Bodies. Skilled in managing audits (MDSAP, ISO), maintaining robust Quality Management Systems (QMS), and sterilization processes within the Medical Device and Healthcare sectors.
Experience
Regulatory Affairs, Senior Manager
Apr 2017 — Present · Mentor, OH, US
Education
Gannon University
Bachelor of Applied Science (B.A.Sc.), Microbiology and Chemistry
1979 — 1984
Golden Gate University
Master of Business Administration (MBA)
1988 — 1989
Skills
- Quality Management
- Six Sigma
- Leadership
- Training
- Quality Assurance
- Quality Auditing
- Management
- Project Management
- Minitab
- Healthcare Compliance
- Lean Tools
- Lean Six Sigma
- Healthcare Management
- Healthcare Improvement
- Process Improvement
- Continuous Improvement
- Cross-Functional Team Leadership
- Process Quality Improvement
- Microsoft Office
- Microsoft Excel
- Microsoft Word
- Quality System
- Root Cause Analysis
- Lean Manufacturing
- Dmaic
- Business Process Improvement
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