Responsible for Spine Division Quality Assurance and Regulatory Affairs Organizations.The QA/RA Team is staffed across three operating sites in the US and France.• Responsible for Quality Management System Integration project (QSI) to combine 4 quality systems into one common system to improve QMS effectiveness and efficiency (30% reduction in procedures). Reduced EU notified bodies from three to single notified body for the entire division.• Quality System Integration Project included overhaul of foundational QMS subsystems including: Design Controls, Regulatory, CAPA, Post Market Surveillance, Management Controls, Documentation, Supplier Controls, and Production/Process Controls.• Completed QMS risk-based remediation project to improve the compliance status for the division. In 2013, two FDA QSIT inspections were completed with zero 483 observations.• Regulatory Affairs Team has achieved over 18 FDA 510(k) clearances. • Supported network optimization effort that included a site closure which required relocation of operations and manufacturer of record/product labeling registration changes worldwide.

Responsible for Quality System Management of the North America Supply Chain for Ecolab Plants and supplier network. Quality Management Representative responsible for network Quality System Policies to support FDA drug, ISO 9001, and EPA regulations. Managed staff of 7 corporate resources and 11 Plant Quality Managers within the US.

Supplier Quality Assurance Director responsible for supplier quality assurance across 4 plant sites (St. Paul, Maple Grove, Ireland, and Puerto Rico) in the Cardiology, Rhythm, and Vascular (CRV) Division.•Lead QA Director role for integration of 2 different Supplier Quality Systems within BSC (CRM and CV Division). Phase I efforts include creation of common quality system processes including: supplier assessments, approved vendor list, supplier corrective actions, component qualification, and associated metrics.•Selected for initial Emerging Executive Leaders training across BSC Network.•MN Supplier Quality Assurance Organization includes 2 sites with 7 Managers and 70+ QA indirect resources•Champion for CAPA Process Kaizen in 2009 that drove significant process efficiencies and standardization.•Implemented standard risk based statistical sample size methodology for component qualifications, process validations, and design verification testing.•Deployed enhanced purchasing controls with suppliers including acceptance activity verification reports, enhanced supplier assessments with risk factors, and creation of a supplier guidebook. Purchasing controls used to manage supply chain in excess of 250 suppliers – aligned with GHTF Guidance for Supplier Controls.•Member of core Director Group that defined plan to clear FDA Warning letter. Warning letter was lifted during first FDA inspection cycle. Managed focused review of Purchasing Controls with FDA during inspection.•Managed plant using Strategic Quality Process with clear metrics: 41% reduction for in-coming component lot rejects, 70% reduction for in-coming inspection cycle time, 88% reduction in units associated with a ship hold, 100% on-time supplier assessment performance, and zero component related field actions.•Member of Product Performance Committee for review of field trends and associated CAPA plans.

Manager responsible for transfer of new products to the Puerto Rico plant from St. Paul and California. Transfer process included completion of equipment validations, process validations, and implementation of quality control plan. •Delivered Cardiac Surgery next generation vein harvesting device per project plan milestones. Top score on project metrics for high quality, time to market, and compliance. •Implemented manufacturing line 5S audit program on new product lines.•Tasked to support the CRM responses to the FDA findings in the STP Plant. Core member for process enhancements related to acceptance activities and associated validation requirements.

Manager – Operations Quality – Puerto Rico Plant (2003-2005)QA Manager at dedicated manufacturing site in Puerto Rico. Responsible for quality system performance in support of three business units (Cardiac Rhythm Management (CRM), Cardiac Surgery (CS), Vascular Intervention (VI)).•Selected to participate in international management rotation – Puerto Rico. •QA Manager lead for external quality system audits of site by FDA and British Standards Institution (BSI).•Completed Green Belt Certification for DMAIC process.•Participated on CRM wide core team to create standard CAPA training courses and associated tests.•Implemented electronic review and approval process for VI and CS document change orders which reduced cycle time for approvals by 75% and supported a reduction of 2 headcount in documentation group.•Implemented a standard safety risk management process (ISO 14971) across the three business units.•Established ISO 13485 key process methodology for the Puerto Rico Quality System.•Recognized as Top Ten Plant by Industry Week in 2004 - QA representative on site management team.•Leader for QA Team responsible for conducting CS product recall and associated CAPA due to field performance.Manager – Operations Quality – St. Paul Plant (2002-2003)QA Manager responsible for the quality system performance and effectiveness for the St. Paul Plant.•Lead QA Manager for design and delivery of paperless document change order system (ECO System). Implemented across 3 BSC CRM plants (St. Paul, Ireland, Puerto Rico).•Core team member for development and implementation of safety risk management program (ISO 14971)

Project Engineer in support of Trident Class Submarine reactor plant operations.