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Click here or scroll down to respond to this candidateCandidate's Name
Worcester MA Street Address
EMAIL AVAILABLE PHONE NUMBER AVAILABLECAREER SUMMARYQuality Engineer Senior Quality Engineer Quality Manager Assembly SupervisorResponsible Quality professional adept at providing guidance, leadership, and support for the quality of products and operations while ensuring all activities conform to applicable local and international regulations in conjunction with company standards and requirements.Experienced in creating and managing Quality Management Systems processes and procedures for Medical, Automotive and Aerospace industries. Performance of internal and external audits to assess the effectiveness of a Quality Management System.Designated Management representative.Strong background in customer and supplier interactions.Proficient in identifying and addressing areas of non-compliance by leading root-cause analysis and problem-solving teams.AREAS OF EXPERTISEQuality Systems ISO 9000 ISO13485 AS9100 IATF16949 Quality Management Quality Management Systems Internal Auditing External Auditing Quality Control Quality Assurance Product Quality Supplier Quality Process Capability SPC Validation PPAP IQ OQ PQ FAI Corrective Action CAPA SCAR 8D 5Why Fishbone Problem Solving Continuous Improvement FMEA Lean Manufacturing Six Sigma SSGB SSBB Microsoft ERP MRB Communication Leadership Risk Analysis clean rooms Sterilization Injection Molding Minitab Gage R&RPROFESSIONAL EXPERIENCEQuality ManagementImplementation of ISO 9001, AS9100 Quality Management systems. Maintenance of ISO 9001, ISO13484, AS9100, TS16949 Quality Management systems, Designated Management representative.Development of Standard Operating Procedures to incorporate into the QMS.Developed and maintained associate Training matrix, Approved supplier Lists, FMEA s, Control Plans, FAI and Validation protocolsEvaluated and analyzed data to identify trends, performance metrics and areas for improvement.Managed continuous improvement activities including procedural changes to improve processes and/or equipmentLed Lean six sigma initiatives and training for associates in six sigma practices.Planned and conducted Management reviews.Executed regular audits of production processes, products and suppliers to ensure compliance with quality standards and specifications.Quality EngineeringIQ/OQ/PQ /Validation Protocols, reviewed, edited, and approved internal and contract manufacturer protocols.Verified execution of protocols, ensured completeness of documentation and conformance to GMP guidelines.Supported improvements to existing processes and development of new processes by participating on cross functional teams which included Program Directors, Program managers R&D Engineers, Manufacturing Engineers Regulatory and Compliance personnel from Customers, Internal Corporation and the Contract Manufacture(s).Documented and approved changes to products through the Engineering Change Order process (ECO).Initiated MRB Activities, Ensured proper containment of suspect material. Chaired MRB meetings and ensured activities were properly executedAccountable for completing CAPA S assigned both internally and from customers.Maintained a strong relationship with suppliers to prevent quality issues by ensuring requirements which could affect product quality during production are clearly understood and accepted by the supplier.Reviewed, and approved suppliers' drawings, processes, specifications, and materials. Ensured changes were properly communicated and understood by suppliers.Authored and distributed Supplier Quality Manual (SQM).Issued Supplier corrective actions and ensured completion in timely manner.Approval of root cause investigation results, and verification that implemented actions were effective in resolving non-conformance.Reviewed and approved Device History Records (DHR) internally and from contract manufacturer(s) for product releases.Verified Sterilization of product and clean room environments via 3rd party testing.Maintained Device Master Records (DMR) and Device History Record (DHR) in PLM systems.Quality Control and Quality Assurance supervisionSupervision of 24/7 Quality control group. Assigned inspectors workloads based on production schedules.Supervised metrology groups to ensure timely completion of First article and Validation inspection reports.Created and Executed Gage R&R studies to ensure proper equipment and techniques were being utilized to measure features accurately.Ensured quality records were current and accurate based on internal processes.Completed FAI and in process inspections as needed utilizing various inspection equipment; handheld devises included Calipers Mics gage pins / blocks, profilometers, thread gages operated automated systems: optical comparators, CMM s, OGP s pressure decay testers.Coordinated calibration activities for gages and equipment either through internal and outsourced resources.Assembly Department SupervisionSupervision of assembly department, cells included manual operations and, semi-automated processes conducted in white room and cleanroom environments. Equipment utilized included sonic and linear vibrational welders solvent gluing, pad printers, thermal transfer printers and electric molding press machines.Monitored Cleanroom environment for cleanliness, measured and recorded particle counts. Confirmed bioburden testing conducted and actions take for.Ensured preventative cleaning actions executed and recorded on schedule.Training of associated to ensure approved process were followed and properly documented. Retrained and documented training on processes changed due to ECO revisions and or process improvements.Monitored production rates and quality levels, yields under 95% would initiate corrective action investigation.Coordinated with Production Control to ensure proper inventory levels maintained, customer requirements fulfilled.EDUCATIONBachelor of Science Industrial Technology 1991- University of Lowell, Lowell MALean 6 Sigma Green Belt 2007 - Siemens -VDO Huntsville AlabamaCertificate in lean Manufacturing 2009 - Manchester community College, Manchester CTLean six sigma Black Belt - 2012 - QPS institute Marlborough MAWork HistoryColumbia Tech-Engineering Division, Westborough, MA Sept 2021 April 2024Prototype manufacturing with intent to scale projects into full volume production.Senior Quality EngineerTecomet, Woburn MA April 2021-September2021Manufacturer of metal components used for medical devices. Processes utilized, CNC machining and photochemical etching.Quality Engineer Contract PositionDePuy Synthes -Spine Division Raynham, MA October 2020- March 2021OEM of a medical device used for minimally invasive spinal operations.Supplier Quality Engineer Contract PositionHologic Incorporated Marlborough, MA July2019-May 2020A Medical Technology company focused on women s health.Supplier Quality EngineerSathorn Corporation, Acton MA April 2016-July 2019A CNC contract manufacturer supplying custom components to Aerospace, Medical, and commercial markets.Quality ManagerMaterion Corporation Westford MA September 2015-December2015Global supplier of precision optical components for Aerospace, Medical, and commercial markets.Quality Engineer - Contract to perm position.Dielectrics Incorporated Chicopee, MA March 2015-May 2015Contract manufacturer specializing in bonding thin film materials utilizing RF welding processes.Quality Engineer - Contract position.Injectronics Corporation Clinton, MA May 2013-December 2014Injection Molding company specializing in molding and assembly of medical components.Quality EngineerTrelleborg Sealing Solutions Northborough, MA December 2011-May 2013Manufacturer of rubber seals gaskets and diaphragms for the Aerospace industry.Quality ManagerRes Tech Corporation Hudson, MA December 2010-December 2011Plastic Injection Molding of components for Automotive, medical and commercial marketsQuality ManagerABA-PGT Manchester, CT May 2007-December 2010Plastic Injection Molding of components for Automotive, medical, and commercial marketsQuality EngineerC-Plastics Corporation Leominster, MA March 2005-May 2007March 1994-March 2005Plastic Injection Molding of components for Automotive, medical, and commercial marketsQuality supervisor / Quality Manager/ Assembly ManagerCycles Incorporated Sterling, MA March 2003-March 2005Plastic Injection Molding of components for Automotive, medical, and commercial marketsAssembly Manager |
