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ExperienceCIRTEC MEDICAL QUALITY MANAGER DECEMBER 2023 PRESENTMedical Device Contract manufacturing for components and finished devices. - Class II & Class III medical devices.Operations Quality Engineering support (manufacturing).New Product Development - Solution provider for complex engineering projects in a fast-paced environment.Management of engineers and inspection teams (30 total employees) for the company.Quality Systems Management representative for internal and external audits including FDA inspection.CAPA leader and coachSupport for continuous improvement projects and initiatives.ABBOTT LABORATORIES/SJM QUALITY ENGINEERING MANAGER JUNE 2015 NOVEMBER 2023Medical Device Divisions supported: Structural Heart, Electrophysiology, Neuromodulation - Class II & Class III medical devices and accessoriesOperations Quality Engineering (manufacturing) - Development of Quality plans, validation protocols (IQ, OQ, PQ, PPQ) including Master Validation strategies, procedures, and manufacturing processesNew Product Development program manager - Solution provider for complex engineering projectsSupplier Quality Engineering manager for multiple sitesManagement of engineers and inspection teams including contractors (23 total) for the divisionQuality engineering support for manufacturing and distribution centersAbbott CAPA certified, leader and mentor across multiple divisionsQuality System improvement leaderResponsible for Regulatory and audit compliance support for internal, external audits (BSI - ISO 13485, Microbiology, Country Specific Audits, FDA)Established and reviewed Quality Agreements with external and internal suppliersSupported cost saving initiatives, acquisitions, and continuous improvement projects with global impactGLOBAL TRAFFIC TECHNOLOGIES QUALITY MANAGER JUNE 2013 JUNE 2015Quality, Safety and Compliance ManagerDeveloped and managed a global level quality and compliance programQuality management process owner for the new product development programsManagement of contract manufacturers and development of a supply chain programCompleted ISO 9001:2008 recertification audits with no audit findingsMaintained a service and repair department with a 98% customer satisfaction ratingSafety manager who was responsible for developing and maintaining the company health and safety programsHEARTH AND HOME TECHNOLOGIES SR. SUPPLIER QUALITY ENGINEER SEPTEMBER 2012 JUNE 2013Supplier Quality Engineer responsible for supplier evaluation and managementDeveloped quality audit program and achieved measurable improvement and cost savings with a diverse supply baseMELLO SMELLO DIRECTOR OF QUALITY MAY 2010 MAY 2012Developed and implemented an ISO compliant Quality System - Established quality policies and proceduresRepresented the company during audits and improved customer relationshipsManaged multiple site compliance to FDA and cGMP for this printing and packaging supplierEstablished a plant training and change management processSQA SERVICES LEAD SUPPLIER QUALITY ENGINEER JANUARY 2010 SEPTEMBER 2010Worked with Medtronic Neuromodulation and Rockwell Collins in providing Supplier Quality Assessments and improvement projectsGuided suppliers in the development of control plans, PFMEA, SPC and process validation (IQ, OQ, PQ)Experience (cont.)TEAM INDUSTRIES SUPPLIER QUALITY ENGINEER JANUARY 2007 SEPTEMBER 2009Created the Supplier Quality programCAPA leader who improved relationships with both suppliers and internal customersISO 9001 Internal Quality Auditor and quality system management leaderROBERT HALF TECHNOLOGY IT CONSULTANT JANUARY 2002 JANUARY 2007Network Infrastructure DevelopmentSite Management, budgeting, and management of external suppliersBusiness Systems Analyst for HealthCare remediation teamSHELDAHL INC SENIOR TECHNICAL ANALYST 1995 - 2001Quality Engineering and Research supportEnterprise IT supportADVANCE POSSIS TECHNICAL MEDICAL DEVICE CONSULTANT 1994 1995Surgical Instrument TechnicianQuality Assurance for instruments used in vascular, orthopedic and neuro surgical applicationsDAYCO PTI QUALITY ASSURANCE TECHNICIAN 1987 - 1994Quality Engineering technician and Research support for automotive industry supplierEducationBACHELORS DEGREE BUSINESS COMMNICATION UNIVERSITY OF WISCONSIN RIVER FALLSCoursework in Business Administration and CommunicationASSOCIATE DEGREE ANIMAL SCIENCE/ANIMAL HEALTH UNIVERSITY OF MINNESOTA WASECAAnimal Science Major with emphasis in animal healthSkills and AccomplishmentsSKILLSQuality Engineering Management: Management of employees, manufacturing quality processes and deliverablesQuality Systems Development and Sustainment: Development and support of quality systems across global sitesQuality Planning and Regulatory Compliance: Medical Device, Automotive, Aerospace industriesSystemic Problem Solving: NCMR, CAPA, SCAR, SCR experienceNew Product Development New Product Development Engineering Manager for Medical Device companyValidation Protocol creation, execution, review, and trainerMedical Device Manufacturing Quality Engineering manager for major medical device companiesEngineering and Supply Change Manager Provided engineering solutions and managed change in global supply chain operations.Certifications: Abbott certified CAPA Initiator, Investigator, Resolution Plan Developer and Approver, SQA Services associate and auditor certification, ASQ Certification, Microsoft Certified ProfessionalSoftware: Microsoft Office, EPIQ, SAP, Minitab, CATsWeb, WindChill, AgileProcesses: NCMR, CAPA, SCAR, SCR, Non-Conformance, Medical Device regulations, ISO 9001, ISO 13485, Quality Planning, Process Development, Design Input, Design Selection, Design Verification and Validation, Process Validation IQ/OQ/PQ/PPQASSOCIATIONSAmerican Society of Quality (1995 Present)Midwest Global Trade Association (2013 -2015)American Endurance Ride Conference Welfare committee (2016 Present)Upper Midwest Endurance and Competitive Ride Association (2001 Present) |