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Click here or scroll down to respond to this candidateCandidate's Name
Street Address Rutherford StNew Britain, CT Street Address
PHONE NUMBER AVAILABLE (cell)EMAIL AVAILABLESummary of QualificationsExtensive experience in QA/RA within the medical device industry adhering to FDA (21 CFR 820), ISO13485 and MDD requirements with regards to documentation, analysis and reporting along with familiarity with ISO9001 and AS9100; ASQ Certified Quality AuditorEmployment HistoryQuality Associate II3/2021 to 6/2024 Northeast ScientificPrepare internal audit schedulePerform internal quality auditsComplaint handling including investigations and reporting to FDA asappropriate.DHR reviewReview and approve documents (SOPs, work instructions, etc)Revise documentsParticipate in 2nd and 3rd party auditsQMS Supervisor11/2016 to 3/2021 Connecticut Spring & Stamping, Farmington, CTHost 2nd and 3rd party auditsManage and train internal quality auditing teamConduct internal quality audits and supplier auditsAudit plan preparationManage document approval processDocument controlMonitor supplier performanceSecondary DQR (Collins Aerospace, Arkwin, GE, Parker Stratoflex, Parker CSD, PW Power Systems, Goodrich Triumph, Sikorsky, Pratt & Whitney)Quality & Compliance Administrator7/2015 to 8/2016 Diba Industries, Danbury, CTInternal quality auditsComplaint investigation and reporting results to customersDevelop and maintain RoHS status of product in ERP systemREACH and RoHS requestsProvide assistance to In-Coming InspectionRegulatory Affairs Specialist1/2013 to 6/2015 i-Health, Cromwell, CTReview consumers complaints and adverse event reports to determine necessity of investigationPerform trend analysisCollaborate with suppliers to determine course of complaint or adverse eventinvestigationMaintain Complaint LogMaintain Adverse Event LogReview complaint and adverse event product returnsAuthor reports for complaint and adverse event closureSubmit MedWatch reports to the FDAProvide cGMP, complaint and adverse event trainingConduct research and report findings on various regulatory issuesQuality Assurance Engineer6/2011 to 6/2012 Insulated Wire-Microwave Products Division, Danbury, CTAdminister CAPA processRespond to CAPA requests from customersDirect and perform internal quality auditsReport audit findings to managementDesign calibration database in Microsoft AccessProvide training in use of calibration databaseDirect activities for calibrationDevelop strategies for supplier qualityCalculate and report supplier quality scoresAS9100 certification project leaderProvide training plant-wide with regards to AS9100 certificationLead AS9102 First Article efforts directing inspectors effortsArrange source inspectionMetrology Inspector6/2010 to 6/2011 Smiths Medical North America, Southington, CTInspection of tooling used in injection moldingInspection of tooling used in automated assembly of IV cathetersPreparation of inspection plans for internal use and for suppliersProduct Analyst5/2002 to 4/2010 CooperSurgical, Inc., Trumbull, CTDesign and maintenance of complaint database in Microsoft AccessAssess complaints to determine course of investigation and reporting activitiesCoordinate complaint investigation within the organization and with suppliers, as neededPrepare and submit Medical Device Reports (MDRs) to the FDA and other agencies, as requiredAnalyze complaint trends to facilitate corrective/preventative action (CAPA)Report complaint trends to senior managementProvide complaint awareness trainingServe as Recall Coordinator by collecting sales data of the subject product, preparing of customer notification and expediting the recall units through the work cellPerform internal quality auditsDesign nonconforming material (NCMR) database in Microsoft AccessProvide training in use of NCMR databaseQuality Systems Technician6/2000 to 9/2001 DePuy, Raynham and New Bedford, MAIn-coming inspection of orthopedic tools and components of joint replacement systemsParticipate in new supplier validationOperation of automated CMMMetrology Technician2/1996 to 6/2000 Johnson & Johnson Medical, Southington, CTInspection of tooling used in injection moldingInspection of tooling used in automated assembly of IV cathetersPreparation of inspection plans for internal use andIn-coming inspection of IV catheter componentsDesign calibration database in Microsoft AccessEmployee of the Month (3 time recipient)Quality Recognition AwardEducation10/2007 to 10/2009 Albertus Magnus College, New Haven, CTMaster of Business Administration6/2001 to 12/2006 Providence College, Providence, RIBachelor of Science, AccountancyCertificationsASQ Certified Quality AuditorCert# 74268 Expires 6/30/2027 |
