David Slavin Email and Phone Number

Development and management of the Quality Management System• Simplified an overly burdensome quality system without sacrificing compliance.• Improved training compliance from 50% to 93% by developing accountability within each department • Instituted cross functional CAPA Review Board resulting in reduction in CAPA closure time by 50%.

Director, Quality Assurance; Maternal Infant Care (2008 – 2009)Director, Quality Assurance; GEHC Home Health (2009 – 2010)Director QA/RA Vital Signs Devices (2010 – 2012)Assured compliance to the Medical Device QSR, MDD and the GEHC Global QMS at each manufacturing site within the business. As Director QA for Maternal Infant Care, managed QA team and compliance at sites in Maryland; Bangalore, India; and Ankara, Turkey. As Director QA/RA Vital Signs Devices managed QA team and… Show more Director, Quality Assurance; Maternal Infant Care (2008 – 2009)Director, Quality Assurance; GEHC Home Health (2009 – 2010)Director QA/RA Vital Signs Devices (2010 – 2012)Assured compliance to the Medical Device QSR, MDD and the GEHC Global QMS at each manufacturing site within the business. As Director QA for Maternal Infant Care, managed QA team and compliance at sites in Maryland; Bangalore, India; and Ankara, Turkey. As Director QA/RA Vital Signs Devices managed QA team and compliance at sites in New Jersey, Colorado, Pennsylvania and Shenzhen, China. Supervised four manager level direct reports and 11-12 indirect reports.• Achieved successful results in five FDA inspections of sites directed. For each inspection, FDA classification was either NAI (no action indicated) or VAI (voluntary action indicated).• Successfully transitioned all sites to the GE Healthcare global quality management system. Show less

Led Quality and Regulatory affairs for this $50 million privately held in-vitro diagnostics company. Managed Quality team consisting of Quality Engineering, Quality Operations, Quality Systems/Regulatory, and Reagent Technology Quality.• Receiving inspection – reduced time from receipt to component release by 30% as a result of eliminating unnecessary inspection.

Managed Quality Operations projects intended to drive improved quality, reduced risk, lower costs and improved “FDA readiness”.WW Quality Systems and Compliance Manager (2004 – 2005)Managed Ethicon field actions and communication with FDA. Supervised two Senior Project Managers. Worked with all Ethicon global sites to assure alignment to Franchise Quality System procedures.

Led the Quality/Regulatory team consisting of Quality Manager, Quality Engineering Manager, Training Manager, Documentation Systems Manager, and EH&S Manager. Directed Quality teams for five Siemens manufacturing facilities.• Improved key quality metrics (customer returns and final inspection rejections) for four consecutive years.• Upgraded the quality system to ISO 13485-2003 and received certification.• Achieved two successful FDA facility inspections.

Provided leadership to the quality assurance team of this contract medical device manufacturer specializing in device design, complex injection molded plastics, full device manufacturing, packaging and sterilization.• Returned to MedTech, having left two years earlier, at the request of the owner after a difficult FDA inspection. Significant improvement in compliance, resulting in two consecutive FDA inspections with no significant 483 observations.• Achieved ISO 9002 certification in… Show more Provided leadership to the quality assurance team of this contract medical device manufacturer specializing in device design, complex injection molded plastics, full device manufacturing, packaging and sterilization.• Returned to MedTech, having left two years earlier, at the request of the owner after a difficult FDA inspection. Significant improvement in compliance, resulting in two consecutive FDA inspections with no significant 483 observations.• Achieved ISO 9002 certification in 1997. • Successfully transitioned the quality system to meet the requirements of FDA’s Quality System Regulation. Show less