Timothy LaMond

Experience

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  Baxter Healthcare

  Aug 2001 - Dec 2006

  Quality Assurance Technician

  Working in the Quality Department, Proofread and addressed the facilities documentation for Corporate and FDA compliance including but not limited to Labeling, Packaging, Device Master Records, Device History Records, and Process Validations.Trained over 300 employees, in all disciplines, for all FDA and Corporate compliance requirements.Through a combination of organizational, people/communication skills and tenacity, drove countless change packages through an arduous process.• Created Device Master Records (DMR) for all devices manufactured at the Tampa Bay Facility.• Composed process flow-charts for all devices manufactured at the Tampa Bay Facility.• Developed Line Clearance procedure for manufacturing.Production Technician (3/2002-3/2004)Worked with Arena, System 1000 and Meridian Kidney Dialysis devices to test, calibrate, troubleshoot and repair, including documentation of tests and non-conformance reports. Worked on numerous Process Validations; Dialyzer cartridge, New Device Arena, HomeChoice as well as the Meridian Blood Leak Detector Protocol, set-up test equipment ran investigative testing at Baxter Healthcare Research & Development and Manufacturing facilities.• Improved quality of product by introducing better quality electronics and more compliant assembly and testing processes. Including a better understood and more productive process as well.Assembled, tested, calibrated, troubleshot and repaired Arena, System 1000 and Meridian Kidney Dialysis devices. Supported with documentation of tests and non-conformance reports. Revised System 1000 Manufacturing documents.• Placed the test steps into order of test performed and at the appropriate reading level for the intended audience, which enhanced production flow by 30% and clarified testing procedures.• Consolidated testing equipment to one area, which increased productivity by 30%. Show less

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  Advanced Biomedical Consulting (ABC), LLC

  Apr 2007 - Apr 2008

  Independent Consultant FDA Compliance

  Independent Consultant, FDA Compliance Division Watson Laboratories (Andrx Corporation) Pharmaceutical Solid Dose Pharmaceutical Manufacturer, Ft. Lauderdale, FL• Equipment/Process Validation Protocol Generation• Process Validation Protocol Execution for Controlled and Non-Controlled SubstancesBausch and Lomb, Pharmaceutical and Medical Device Manufacturer and Distributor, Tampa, FL• Equipment Validation Protocol GenerationGensco Laboratories, Inc Solid Dose Pharmaceutical Distributor, Inverness, FL• Original Standard Operating Procedure Development for Controlled and Non-Controlled Substances Show less

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  Stryker Sustainability Solutions

  Mar 2009 - Dec 2013

  QA Engineering Technician

  Managed Incoming Inspection & Calibration Department activities, performed first inspections, calibrations, managed calibration database for five yearsReduced KEMA Audit findings in Calibration Department rewrote calibration procedures to current industry standards15+ External Supplier/Vendor Audits to FDA 21 CFR 820, ISO 13485 for Medical Devices, ISO 17025, ISO 10012 and ISO 540Z regulations for CalibrationReview and Approval of all equipment related internal documentsEquipment/Process Validation Protocol development, execution, review and approvalInvestigation of Medical Device Complaints MDR and non-MDR Show less

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  JMI Resourses at Cutrale Citrus Juices

  Nov 2014 - Jun 2015

  Quality Assurance Lab Tech

  Worked in a wet lab Calibrating equipment and chemicals for titration used in the testing of orange juice products for uncorrected Brix, acid, pH and calculate Ratio and corrected Brix. Reconstitute OJ concentrate to two different Brix.Check oil and Diacetyl content. Determine solids (pulp) content. Determine color. Check viscosity. Check for defects, peel, seed, Hesperidin and any other foreign material.Retained samples of the OJ products for USDA, FDA, and client verification testing. Food and Drug Association, Florida Department of Agriculture and USDA regulated Show less

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  MICRO

  Jul 2015 - Dec 2016

  Quality Assurance Technician

  First piece, incoming, and in process inspections. Using a variety of calibrated precision measurement equipment and top of the industry electronic vision measuring stations. Working in the precision medical device, aerospace and automotive industries. Using injection/insert molding, MIM/CIM to fabricate tube assemblies, a variety of blades, scissors, stapling and biopsy devices for use in laparoscopic, endoscopic and arthroscopic minimally invasive surgical instruments.