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Title Medical Device Quality Assurance
Target Location US-NJ-Raritan
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Phone (765) 240-4655  E-mail EMAIL AVAILABLE https://LINKEDIN LINK AVAILABLE?trk=PHARMA/MEDICAL DEVICE SENIOR OPERATIONS PROFESSIONALExperienced and results-driven production professional with over two decades of proven leadership within the pharmaceutical and medical device manufacturing sectors. Known for adeptly merging technical expertise with strategic management acumen, consistently driving operational excellence, and fostering high-performance teams. Proven record of streamlining operations, combining resources, and spearheading programs that positively affect staff efficiency, quality assurance and bottom-line profits. Highly effective in collaborating with customers and support groups, to ensure product is manufactured within specifications, on time, and within budget.Expertise includes. Strategic Planning  Personnel trainingMedical Device Manufacturing  Budgeting  ERPPharma Solid Dose/Liquid Mfg.  Q A  Customer ServicePROFESSIONAL EXPERIENCEINTEGRA LIFE SCIENCES 2021-PresentSenior Operations ManagerManaging a medical device manufacturing site with sixty-five colleagues. Responsible forensuring continuous operation with no facility or manufacturing breakdowns. Only IntegraSite to deliver or exceed build every month during my leadership. Stakeholder inconsolidation of Lafayette and Columbia Sites.KALSEC 2017 - 2021HTFC Finishing SupervisorManufacturing Supervisor within the Food Industry at Kalsec in Kalamazoo MI. Exhibited leadership ability with skill in getting the best out of direct reports. Lead an effort to reduce inventory that was scanned to incorrect bins and drastically reduced instances of this while changing culture to maintain these low levels as the norm. Part of a team that has held on-time delivery to above 99% since March of 2017.ZIMMER BIOMET 2015 -2017Production Manager Sterile Packaging / FoundryManaged a staff of 40 operators, specialists, and group leaders in oversaw Foundry manufacturing operations of this medical device manufacturing company. Hired, trained and evaluated new employees. Monitored quality assurance and performed long range planning.Dramatically improved operator output and customer service by developing and assigning targeted work teams to produce in specific areas.Effectively addressed the potential for operator burnout and delivered cost savings by creating an overtime schedule to assist production managers and planners during periods of high activity.Managed a cross-functional team of sterile packagers, and auditors and coordinated the centralized packaging and shipping activities for this medical device company which has sales of over 2 billion dollars.Developed output boards to measure packaging activities, using these measurements to drive continuous improvements.Created operator assignment boards for the expeditious deployment of sterile packaging teams.Implemented daily toolbox meetings which conveyed essential Quality, Cost, Delivery, and Safety information across all shifts.KIK CUSTOM PRODUCTS 2013-2015Plant Manager / Project ManagerManaged Projects working with multiple customers, with responsibility for all new product launches and current product improvements.Launched multiple prescription liquid products with responsibilities for CBE30 regulatory submissions.Responsible for aerosol packaging changes and improvements on multiple customer accounts.Managed Manufacturing, Compounding, Line Maintenance, and Chemical Warehouse Operations.Responsible for day-to-day operations including continuous improvements.Directly responsible for the implementation of a newly constructed pharmaceutical facility within an aerosol manufacturing facility.PERRIGO 2006-2013Plant ManagerResponsible for Dispensing Operations in a 24/7 operation at two plants.Responsible for process improvement and quality improvement projects.Responsible for all aspects of raw material control.SCHWARZ PHARMA 2001-2006Production ManagerManaged manufacturing and packaging operations.Managed production supervisors, Team leaders and 25 production operators.EDUCATIONMaster of Science, Reg. and Qual. Comp., Purdue University, West Lafayette, INBachelor of General Studies, Indiana University, South Bend, INAssociate of Science, Criminal Justice, Indiana University, South Bend, INUS Army, Military Police Officer, Communications Specialist, E4, Honorable Discharge

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