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

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

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.

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.

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.

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.

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.

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