Donna Campbell
Regulatory / Quality Medical Device Professional
- Role
- Director of Quality and Regulatory at Viscus Biologics LLC
- Location
- Cleveland, OH, US
- LinkedIn followers
- 500 followers
About Donna Campbell
At the heart of Viscus Biologics\' commitment to regulatory precision, my role as Director of Quality and Regulatory fuses ASQ-certified expertise with a strategic approach to compliance. With a deep understanding of FDA and ISO standards, I lead our efforts to maintain impeccable quality and regulatory practices, ensuring our medical technologies meet global benchmarks.My tenure as Senior Client Manager at BSI honed my proficiency in developing quality management systems and spearheading training program for ISO 13485, ISO 9001, MDSAP and Lead Auditor. These experiences, coupled with a talent for diplomacy, empower me to cultivate robust relationships and drive continuous improvement, securing our reputation for excellence in the ever-evolving medical device landscape.
Experience
Director of Quality and Regulatory
Sep 2023 — Present · Cleveland, OH, US
Managed comprehensive quality and regulatory audit programs, enhancing compliance and operational efficiency. • Developed and implemented innovative strategies for Quality Management System effectiveness, aligning with corporate objectives. • Established quality plans for new products, ensuring ongoing compliance and boosting customer satisfaction.
Education
Indiana Wesleyan University
Bachelor, Management
2010 — 2012
LCCC
Associate, Medical Technology
1989 — 1991
Skills
- Iso
- Sop
- Fda
- Calibration
- Lean Manufacturing
- Continuous Improvement
- Software Documentation
- Quality Control
- Gmp
- Root Cause Analysis
- Biotechnology
- Process Engineering
- Team Building Facilitation
- Quality Management
- Design Control
- Kaizen
- Strong Business Acumen
- R&D
- Quality System
- V&V
- Process Simulation
- Spc
- Six Sigma
- Quality Auditing
- Glp
- Testing
- Medical Devices
- Capa
- Iso 9000
- Manufacturing Operations
- Dmaic
- Operational Excellence
- Technology Transfer
- Fda Gmp
- Iso 13485
- Regulatory Affairs
- Change Control
- Quality Assurance
- Minitab
- Value Stream Mapping
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