Donna Campbell

Director of Quality and Regulatory @Viscus Biologics LLC

Cleveland, OH, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Sep 2023 — Present

Director of Quality and Regulatory @Viscus Biologics LLC

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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

2010 — 2012

Indiana Wesleyan University

Bachelor, Management

1989 — 1991

LCCC

Associate, Medical Technology

SKILLS

IsoSopFdaCalibrationLean ManufacturingContinuous ImprovementSoftware DocumentationQuality ControlGmpRoot Cause AnalysisBiotechnologyProcess EngineeringTeam Building FacilitationQuality ManagementDesign ControlKaizenStrong Business AcumenR&DQuality SystemV&VProcess SimulationSpcSix SigmaQuality AuditingGlpTestingMedical DevicesCapaIso 9000Manufacturing OperationsDmaicOperational ExcellenceTechnology TransferFda GmpIso 13485Regulatory AffairsChange ControlQuality AssuranceMinitabValue Stream Mapping

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.

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