Ron Harmon Email & Phone Number

Lake Forest, Il

Post Market Quality Assurance, Supplier Quality, Software Validation, Manage In-house Inspection Center, Machine Validation, Internal and Supplier Audits. CAPA, Risk Analysis

Input, review and close disposable and hardware complaints for Amicus, CS-3000, and auto-sealersAttend monthly Divisional CAPA meetings and monthly Product Review meetings for hardware and disposablesInstitute investigations and write responses with results for the National American Red Cross Quality Group in relation to problem reports sent to Fenwal for hardware and disposables Visit accounts with adverse eventsWork closely with Divisional Quality on complaint evaluations, closures, customer letters and CAPALiaison to the National American Red Cross Supplier Quality Group

Reliability and Quality Engineering/Quality Assurance, Research and Development Work within the new Quality System Regulations (QSR) issued by the FDAEvaluation of customer complaints, corrective actions and preventive actions, CAPATroubleshoot field issues that occur at the customer and reported to Clinical Education Group and Field Service EngineersMulti-task projects for multiple teamsConduct internal design control audits, GLP audits, vendor audits per corporate procedures dictated by FDA and ISO requirementsMaintain test procedures, data and records per FDA and ISO requirementsPerform FMEA Hazard Analysis of automated medical equipment and related disposable productsInvolved with APQP and Design Reviews of hardware and disposable productsWrite test protocols, final reports, quality statements and standard operating procedures (SOP)Data reviewer and approval of engineering protocols, original data, reports per SOP's, FDA and ISO requirementsInvolved with mechanical testing and electrical testing of medical equipmentIntroduction of new products directly to the customerBudget for test equipment and supplies

Corporate Reliability and Quality Engineering Fenwal DivisionResponsible for prioritizing projects for lab techsResponsible for special Biohazard lab and upkeepSupervised all QC functions in division special mini product plantWork with computers and microprocessorsPerformed instrument repairs and calibrationsRecipient of two Technical AwardsEvaluated customer complaintsEvaluated first piece inspectionsWorked on several different product lines

Business Administration And Management, General

Associate Of Applied Science Degree, Mid-Management

Business Administration