Bruce Corwin Email & Phone Number

Amsterdam, Noord-Holland, Nl

• Lead quality driven programs and transformation initiatives sourced from enterprise level transformations and from NAM Quality strategic transformation roadmap.• Lead crisis-management activities to ensure a rapid, compliant and customer focused solution partnering with appropriate stakeholders such as legal, Environmental Health and Safety, and business unit teams.• Ensure compliance to Philips Quality Management System, FDA regulations and other Regulatory Agencies’ regulations.• Develop and Manage Daily Management of critical KPIs and leading indicators for the oversight of the programs/initiatives within our strategic roadmap to ensure successful and timely execution.• Primary point of contact/leader/quality expert for 3rd party audits representing Service, Sales, and Marketing (North America Market) and manage backroom support teams.

Amsterdam, Noord-Holland, Nl

• Responsible for Quality Transformation of high-risk sites across Philips• Provide Program Management for Global Q&R, Remediation & Integration, and Audit• Perform Due Diligence assessments, Remediation cost analysis for acquisition targets • Develop project plans, establish KPIs for high risk sites and QMS Integration support• Define project resources, establish project team, workstreams and escalation process• Provide monthly program updates and KPI reporting to the Chief Quality Officer and Executive Leadership Team• Manage and conduct audits, analyze audit data to create risk-based heat maps for targeted Remediation and Integration• Develop, Remediate, and Transform ISO 9001 and 13485 Quality Management Systems• Provide External Inspection Readiness training and SME coaching, front room, and back room support• Manage Internal Audit Response Review Team and External Audit CAPAs, communications and objective evidence• Author responses for Warning Letters, FDA 483’s and Notified Body non-conformances

Amsterdam, Noord-Holland, Nl

• Remediation Team Lead- managing enterprise wide Quality and Regulatory compliance projects, develop Quality Improvement plans and conduct remediation activities for high and severe risk sites• Participated in the re-write of the Q&R Merger and Acquisition Playbook• Integrated Corporate level PQMS procedures and standards with site level QMS• Manage KPI scorecards for severe risk sites and present to Quality Leadership Team Compliance Council• Focused on overall compliance and process improvement, including, coaching, mentoring, internal consulting, and inspection/audit readiness activities• Responsible for assisting business units in addressing compliance deficiencies. Identifying and sharing best practices, delivering training on key compliance topics • Conducted an enterprise wide Design Control and Risk Management Assessment through a 5-step process. Reviewed field data, conducted site interviews, reviewed corporate and site level procedures, compiled observations from Design Control and Risk Management files, performed root cause analysis and provided recommendations for improvement• Lead Audit Response and Remediation projects for CAPA, Post Market Surveillance, Purchasing Controls, Receiving Inspection, and Design Controls• Drove the development SME Inspection Readiness offering for training of SME’s on how to prepare for Regulatory Inspections. • Created the Remediation Team Engagement Request and Statement of Work (SOW)• Developed a standardized structured approach to Remediation for consistent results

Monroeville, Pa, Us

Summary:Young DentalProject Manager/Team LeadClass I and II Medical Device & Pharmaceutical Manufacturer, St. Louis, Mo.Quality system improvement team lead. Development of project plan for Quality System improvement project. Update Quality System procedures and processes to ensure compliance with CFR 21, Part 820, 210, 211, EN/ISO 13485, 14971, 14001 MDD 93/42/EEC, CMDCAS. Provide training on procedure and process changes. Report weekly progress to C-level stakeholders.Ambu/King SystemsProject LeadClass I and II, Medical Device Manufacturer, Indianapolis, INDevelopment of Project Plan and resource requirements for NCR Remediation Project. Wrote and managed 483 responses for FDA audit. Successfully developed a defense strategy and rationale for potential 483’s during FDA audit. Developed user requirements and evaluated QMS Software for complaint handling.

Monroeville, Pa, Us

Class II and III Medical Device Manufacturer, West Chester, Pa.CAPA Coordinator managing corporate and regional CAPA’s. Remediate CAPA’s to ensure compliance with FDA regulations. Management of the CAPAs including use of formal problem solving techniques, consistency in execution, completeness of content, clarity of content, and compliance with FDA 21 CFR 820. Provide guidance and instruction on root cause investigation tools and techniques for effective CAPA execution with process owners. Perform compliance and regulatory audits for the US and Europe. Participate in FDA, TUV and QHUB audits. Develop CAPA proof books for QHUB and FDA audits. Train consultants on CATSWeb and ETQ Quality Management systems..

Deerfield, Illinois, Us

Class II Medical Device ManufacturerManage supplier corrective actions, internal corrective actions, field corrective actions, corporate holds, and quarantines. Conduct internal Quality System audits and participate in FDA compliance audits. Complete Tier 1 and 2 Corrective and Preventive Action (CAPA) investigations and participate in monthly CAPA review board meetings. Perform Quality Engineering support and Supervisor responsibilities for inspection staff. Conduct verification and validation for software, equipment and product changes. Develop, revise and review Validation Protocols, Inspection Plans, Test Methods, Manufacturing Instructions and SOP's. Manage timely inspection and release of in-process and finished products. Supervise and train personnel to perform part/device inspections.

Deerfield, Illinois, Us

Responsible for designing, developing, implementing and evaluating, cost effective projects related to product manufacturing process. Cost estimating of major capital budget items and spending of approved project funds. Designed new and improved processes, supervised contractors, requisitioned funds and materials related to the projects. Specified equipment and procedures, document new and revised procedures, trained employees, and optimized existing systems.

Deerfield, Illinois, Us

Manage global customer relationships for Baxter Healthcare’s Apheresis product line. Developed launch and support strategy for new Apheresis device; provided Technical and Clinical Sales presentations. Initiated CAPA’s, field corrective actions, and managed them through closure.

Deerfield, Illinois, Us

Drove servicing product development process (PDP) deliverables and infrastructure required for concept generation through market release for next generation products. Worked with marketing to provide and integrate comprehensive "design for service revenue" planning. Analyzed global market data to develop strategies and tactics for growing a competitive servicing advantage, through enhance product design features and capabilities. Developed economic model to capture and analyze life cycle operating costs. Designed and implemented all technical changes, information and communications relating to Baxter Healthcare Apheresis product line. Managed CAPA’s, global field corrective actions, provided weekly updates to senior management, and managed them through closure.

Deerfield, Illinois, Us

Provided national technical sales support, clinical and technical customer training on Baxter Healthcare’s Hemodialysis, Clinical Data Management Software Suite, Blood Pressure Monitor, Plasma Apheresis and Stem Cell Harvester.

Deerfield, Illinois, Us

Territory management for Virginia, Maryland, North and South Carolina, including clinical and technical training, instrument servicing, service contract sales, inventory management, expense management, for medical equipment and diagnostic hardware/software.

Deerfield, Illinois, Us

Responsibilities: Responsible for territory management including instrument servicing, training, service contracts, inventory, and expense management.

Deerfield, Illinois, Us

Performed calibration, testing, and troubleshooting for Hemodialysis, Peritoneal Dialysis and Reverse Osmosis machines.

Master Of Business Administration (M.B.A.), Business, Management, Marketing, And Related Support Services

Bachelor Of Applied Science (B.A.Sc.), Management And Organizational Leadership