Advanced to this role following reorganization, stepping into the highest global quality position, driving quality and performance across the medical devices business, with full oversight of 200+ suppliers during rapid growth phase. Direct, improve and maintain quality methodologies, processes and procedures, ensuring systems are in compliance / conformance with ISO and FDA quality system standards. Principally guide quality system certifications/accreditations, facility registrations, and internal and external audits. Scope further encompasses contributing to product strategy, product families, and product funnel. Direct high-functioning global team across US, Malaysia, China, Ireland, Germany, and UK.► Established ISO-certified quality organization from scratch in tightly-compressed 8-month timeline, to import medical devices into Europe. Installed management team, structured documentation, and engaged 3rd party auditor.► Strategically support organizational growth, particularly of core business, onboarding double-digit increase in number of suppliers, and triple-digit increase in number of SKUs year over year.► Expertly balance planned growth with ad hoc developments associated with new products and new suppliers, and issued recommendations for to dual source, transition product to McKesson private brand, or other solution.

Significantly expanded position scope upon McKesson’s acquisition of Cypress, a former standalone business of McKesson, specializing in product sourcing and importing for medical devices and OTC products. Directed global and domestic quality for both organizations as well as Physician Sales & Services (PSS) once McKesson Medical/Surgical completed that acquisition. Formulated quality segment of vendor scorecard. Articulated quality statistics to executive leadership.► Steered planning and launch of QC/QA groups in China and Malaysia, fully structuring quality function, including SOPs and documentation, for product inspections at factories prior to shipping that aligned with domestic inspections. ► Defined vendor audit and qualification procedures essential to increasing 1st pass acceptance in factory inspections from 90% to 97.5%. Also led cGMP & ISO audits of all suppliers for imported products.► Migrated product sterilization function overseas, including validation of facilities and products. Collaborated with leader in China with sterilization expertise, who verified validation protocols and proper documentation.

Rapidly advanced to this position, to develop and implement McKesson Brand’s quality system for private label business, new product development process, cGMP vendor audit procedure, and complaint handling and CAPA guidelines. Performed series of on-site audits of manufacturing facilities in China and Malaysia producing medical-surgical and pharmaceutical products. Integrally contributed to due diligence for QA & Regulatory during acquisition of key multi-million-dollar supplier. Collaborated with key suppliers to raise their FDA compliance rates. Additionally, hosted, responded to, and closed the FDA inspection of the kit packing operation.

Merited fast-track promotion to senior role, supporting manufacturing floor by steering in-process QA for liquid filling, packaging, compounding, as well as incoming QA area and document control area. Placed sharp, consistent focus on raising compliance. Drove series of improvements to operating procedures across all 3 areas, in addition to advancements to quality systems company-wide.► Improved cycle time 20%+ in incoming QA area.► Slashed cycle time for controlled document change requests from 50+ days to less than 15 days.► Instituted new batch record system including several advancements toward cGMP compliance.

Advanced through series of increasingly responsible manufacturing support roles, ultimately overseeing 14 QA technicians and serving as manufacturing unit’s expert and liaison for FDA inspections and quality systems. Defined and implemented additional QA procedures to increase cGMP compliance and product quality. Previously, as Product Manager, Technical Product Development - Abbott ARCHITECTTM, integrally contributed to market launch of ARCHITECTTM immunoassay instrument, and won ARCHITECTTM Program Achievement Award 6x. Previous titles all pertain to Abbot Vision System, including: Analytical Quality Assurance Supervisor; Special Project Coordinator; Laboratory Coordinator; and AQA Technician.