Candidate Information Title Quality Assurance Operations Manager Target Location US-MO-Washington Email Available with paid plan Phone Available with paid plan	20,000+ Fresh Resumes Monthly     View Phone Numbers     Receive Resume E-mail Alerts     Post Jobs Free     Link your Free Jobs Page     ... and much more Register on Jobvertise Free
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ExperienceNorth American Operations ManagerLeica Biosystems, Danaher Corp., Street Address   2012Directly responsible for the manufacture of Class I and II medical devices for a large laboratory supply corporation. Manage all levels of operational personnel at three manufacturing locations(Street Address + employees). Responsible for $100M USD OPEX, $5M capital expenditure annually. Played a key role in M&A process (merged with Leica Biosystems and acquired/relocated two manufacturing facilities).Jeffrey HabitzQuality ManagerZagg, mophie Inc., July 2013-March 2020Developed an international quality assurance department for the manufacture, import and distribution of consumer electronics and telecomunication accessories. Managed ~20 quality engineers, managers and technicians to include percision machining and design staff for injection molding. Responsible for injection molding supply base in US, China, Hong Kong, Philippines and other APAC region locations. Worked closely with executive level representatives from Apple, Verizon, Samsung, AT&T, and Best Buy.Biomedical ScienceEnvironmental StudiesWestern MichiganUniversityExecutive Strategic PlanningTeam DevelopmentProcess Efficiency/LeanInjection MoldingFDA, AIB, ISO ComplianceLow Cost Region SourcingSocial ResponsibilityQMS DevelopmentDue Diligence / M&AKey Performance IndicatorsBudget DevelopmentOperations & Quality Assurance Management63139 East CharlestonWashington, MI 48095EMAIL AVAILABLEPHONE NUMBER AVAILABLESkillsEducationQA/RA ManagerThermoFisher Scientific, 1996  2006Directly responsible for product quality and regulatory compliance of several Class I and II medical device manufacturing locations. Played a key role in M&A process acquiring three medical device manufacturing facilities abroad. Chaired the Corporate Regulatory Compliance Committee. Conducted over 50 regulatory audits abroad. Participated in numerous federal/state regulatory inspections with no reported violations (FDA, BATF, EPA, OSHA and DOT). Obtained ISO 13485 certification. Managed anatomical pathology quality control laboratory. Science Based StudiesRochester Adams HighSchoolAccomplishmentsEstablished APAC &Domestic Automotive andElecronics Injection MoldingSupply ChainDeveloped ISO 13485 andISO 9001 Certified QualityManagement SystemsDeveloped and ManagedInternational Manufacturingand Quality Control TeamsRealized >$130M USD byRelocating Four MedicalDevice ManufacturingFacilitiesObtained FDA 510KClearance for ~500 Class Iand II Medical DevicesQuality Management ConsultantEIS Consulting Services., March 2020-PresentContractual agreement to provide business and quality management services. Assisted a large container manufacturer with ISO and AIB compliance in preparation for certification. Developed quality control programs for the manufacture and assembly of consumer electronic products. Created Quality Control Procedures to comply with domestic and international regulations.ProfileResults-driven Operations & Quality Assurance Professional with 20+ years practical experience managing domestic and international manufacturing/quality assurance teams. Proven success deploying ISO, AIB, FDA, CE, UL and internationally certified quality management sysems. Developed pertinent continuous improvement objectives, and key performance indicators for executive review.