New Bedford, Massachusetts, United States
20 year career in quality roles including three successful certifications to different ISO standards, EU MDR and QSR compliance, quality department manager, quality assurance management and design quality engineering for medical device and scientific instrument manufacturers. Supplier auditing, diversified experience includes expertise in metrology, electronics and a variety of manufacturing processes and technology My goal is to continue a career in the Massachusetts area in the medical device industry Specialties: EU MDR and QSR / ISO compliance, design quality engineering, supplier auditing - diversified experience includes expertise in metrology, electronics and a variety of manufacturing processes and technology.
Evaluation, selection and qualification of suppliers, supplier performance monitoring. Conduct supplier audits. Develop procedures to comply with industry and ISO requirements. Responsible for over 100 suppliers ranging from fluidics and pneumatic pump, valve and tubing assembly manufacturers to PCBA’s, cables, machine shops, plastic injection molding houses, plastic and metal tubing manufacturers, foundries,/castings and sheet metal manufacturers. • Created supplier qualification program and procedure to meet demanding requirements of Waters Corp. Critical CleanTM specification – a mass spectrometry/instrument grade cleanliness spec. Managed program, held training event involving top 10 most critical suppliers and gained their successful participation in the qualification program. • Extensive cross functional team based activities in lead role, data driven problem solving processes - successful in reducing failure rates on supplier’s valve manifold assemblies from 5% to less than 1% over a one year period. • Lean Six Sigma Green Belt project team leader – developed improvements to production part approval process. • Established and implemented validation plan for high performance valve components. • Issue CAPAs to suppliers, review and approval of responses. • Created/issued supplier guidance document for effective corrective actions.