David J. Vanella Email & Phone Number
Vice President, Global Quality and Product Regulatory @ Omnicell
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David J. Vanella Location
- Cranberry Township, PA, US
David J. Vanella Work
- 2019 -now Vice President, Global Quality and Product Regulatory @
- 2015 -now Vice President, Quality and Regulatory @
- 2005 -2015 VICE PRESIDENT, QUALITY COMPLIANCE AND REGULATORY AFFAIRS @
- 2001 -2005 DIRECTOR, QUALITY ASSURANCE @
- 1996 -2001 MANAGER, REGULATORY AFFAIRS AND PRODUCT ASSURANCE @
- 1992 -1996 SENIOR REGULATORY AFFAIRS ENGINEER @ Philips Respironics
- 1986 -1992 PRODUCT ENGINEER @
David J. Vanella Education
- Duquesne University
Master of Business Administration (Leadership)
1999-2003 - University of Pittsburgh
Bachelor of Science in Electrical Engineering (Mathematics)
1981-1986
David J. Vanella Skills
- ISO 13485
- 510(K) AND IDE SUBMISSIONS
- REGULATORY STRATEGY
- GLOBAL QUALITY COMPLIANCE
- FDA INSPECTIONS
- QUALITY REMEDIATION
- QUALITY MANAGEMENT SYSTEMS
- NEW PRODUCT DEVELOPMENT
- DESIGN ASSURANCE
- DESIGN CONTROL
- CORRECTIVE AND PREVENTATIVE ACTION PROGRAMS (CAPA)
- MEDICAL DEVICE DIRECTIVE
- ISO 13485-2003 CERTIFICATION
- COMPLAINT HANDLING
- INTERNAL AUDITS
- COMPLAINT SYSTEM ANALYTICS
- PRODUCT SAFETY TESTING
- RISK MANAGEMENT
- VERIFICATION & VALIDATION
- FDA
- Iso 9000
- Leadership
- Manufacturing
- Commercialization
- Product Development
- CAPA
- Quality System
- Cross-functional Team Leadership
- Medical Devices
- Quality Assurance
- Six Sigma
- Regulatory Affairs
- Validation
- Lean Manufacturing
- Supplier Quality
- FMEA
- Continuous Improvement
- Regulatory Submissions
- Testing
- ISO 14971
- Process Improvement
- Global Quality
- Quality Management
- 510K And Ide
- Cross Functional Team
- Sales
- Business Development
- Corrective
- Strategic Planning
- 510K And Ide Submissions
- Iso 13485 2003
- Cross Functional Team Leadership
- Iso 13485 2003 Certification
- Verification And Validation
- Complaint System
- Management
- Public Relations
- Verification
- Corrective And Preventative Action Programs Capa
- Strategy
- Social Media
- 510 and Ide Submissions
- Corrective and Preventative Action Programs
David J. Vanella Summary
- David J. Vanella, based in Cranberry Township, PA, US, is currently a Vice President, Global Quality and Product Regulatory at Omnicell. David J. Vanella brings experience from previous roles at Omnicell, Fresenius Medical Care and Philips Respironics. David J. Vanella holds a 1999 - 2003 Master of Business Administration in Leadership @ Duquesne University. With a robust skill set that includes ISO 13485, 510(K) AND IDE SUBMISSIONS, REGULATORY STRATEGY, GLOBAL QUALITY COMPLIANCE, FDA INSPECTIONS and more. David J. Vanella has 2 emails and 2 mobile phone numbers on RocketReach.
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