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PHONE NUMBER AVAILABLEEMAIL AVAILABLEAs a seasoned Supplier Quality Engineer, I have had extensive quality management systems exposure and experience with external and internal manufacturing across multiple fields and commodities. (Printed circuit board assembly, electro-mechanical assembly, and injection molding processes across multiple quality management systems (ISO 9001, 13485, AS9100, FDA CFR 820, DoD). I am currently looking for employment opportunities and open to new roles at any level.EXPERIENCE:InsuletJuly 2023 Feb 2024Sr Supplier Quality Engineer> Create supplier quality agreements, as required.> Conduct and maintain supplier audits and schedule.> Review/approve supplier process validation protocols and reports.> Review/approve engineering change order requests.> Implement/coordinate Quarterly Quality/Business Reviews with critical suppliers.> Build and maintain cross-functional relationships to communicate and resolve manufacturing/quality/compliance issues.> Create/review deviation requests for validity and corrective action> Support new supplier qualification/assessments> Manage and process supplier corrective action requests (scars) to closureQuanterixFeb 2023 July 2023Sr Supplier Quality Engineer> Tasked with cleaning up the Approved Supplier List Reduce the number of suppliers> Improve supplier selection/evaluation processesCynosure - Westford, MaJune 2021 January 2023Sr Quality Engineer> Develop and circulate supplier scorecard (present monthly to executive team and share with appropriate suppliers).> Create supplier quality agreements, as required.> Improve MRB turn-time and reduce current MRB inventory ($500K reduced to $68k within three months, through weekly meetings)> Conduct and maintain supplier audits and schedule.> Monitor manufacturing of cosmetic creams and ointments through batch records and filling operations.> Improve supplier corrective action request (SCARs) supplier response (RC/CA) and turn-times.> Implement supplier process performance / monitoring KPI metrics (Test and Inspection Yields).> Create/review supplier process validation plans and reports.> Process engineering change requests.> Create and maintain transparent supplier relationships (establish a trusted partnership).> Implement / coordinate Quarterly Quality/Business Reviews with critical suppliers.> Qualify suppliers, maintain supplier files, and approved vendor list from a quality perspective.> Process FAIs as part of supplier and part qualifications> Support or lead CAPA root cause and preventive action tasks> Support external compliance audits (MDSAP- Medical Device Single Audit Program, ISO Certification audits, MDR- European Medical Device Regulation)> Build and maintain cross-functional relationships to communicate and resolve manufacturing/quality/compliance issues.ZOLL Medical - Chelmsford, MaApr 2019 June 2021Sr Supplier Quality Engineer> Supplier development and support> Internal manufacturing support> Create supplier process validation plans (IQ/OQ/PQ) and reports for injection molding equipment/ tooling> Process supplier change requests (SCR) through our Agile product data management tool via engineering change requests (ECR) and engineering change orders (ECO)> Review deviation requests for validity and corrective action> Support new supplier qualification/assessments> Conduct/support periodic supplier assessment, quality, and process audits> Manage MRB for injection molded components> Manage and process supplier corrective action requests (scars) to closure> Assist and drive in CAPA investigations> Address and resolve all supplier-related discrepancies.> Develop quality plans for incoming inspection and supplier final inspection.> Support cross-functional teams to deliver the highest degree of quality and reliability to our internal and external customers.Novotech Inc (via TRN staffing agency) - Acton, MaNov 2018 Feb 2019Quality Engineer-Temp Contract> Responsible for creating the QMS documents, forms, and identifying KPIs for ISO 9001:2015certification. Stage 1 audit was successful (only 2 recommendations noted).> Implementation of QMS, KPI data analysis and drive Corrective Action processesHelen of Troy Health & Home - Marlborough, MaApril 2009 October 2018Supplier Quality Assurance Manager> Responsible for managing and developing supplier quality assurance processes of globalcontract manufacturers. Primary focus is the implementation of supplier quality systems,monitoring supplier performance, corrective and preventive action, supplier's adherence to theSupplier agreements, perform and assist in internal/external audits of quality systems,manufacturing/test processes, fire-health & safety, and code of conduct for adherence ofcontractual and regulatory requirements, ISO13485:2016, ISO9001:2015, SA8000, and FDA.> Review verification & validation protocols and reports (IQ/OQ/PQ) to assure robust productquality and ensure best in class processes, design guidelines, and practices are utilized.> Act as a bridge to transfer product design to manufacturing through manufacturing readinessreviews, process audits, and lessons learned.> Lead periodic quality review meetings with external/internal stakeholders, drive Root CauseAnalysis (RCA), implement robust corrective/preventive actions, and ensure proveneffectiveness.> Identify, analyze and interpret quality data for trends, risks, opportunities, and makeappropriate recommendations to drive improvements.> Respond to customer field issues with CAPAs that are effective in preventing recurrence.> Coordinate root cause/ corrective action for global regulatory complaints through the followingagencies: Bfarm, MHRA, TFDA, FDA.> Single point of contact for all quality related issues between Helen of Troy, customers, andsuppliers.Crane-Azonix Corp - Billerica, MaOctober 2007 April 2009Supplier Quality EngineerMilitary/Marine/Oil & Gas Grade Displays and Military Grade Computers> Develop and drive supplier quality, internal quality, and customer quality initiatives.Responsibilities include, analyze supplier process/quality, customer return and internal qualitydata for possible defect trends and process issues. Performing root cause analysis,implement/close corrective/preventive actions internally and at the suppliers.> Supplier development through process/quality audits, assures suppliers have proper processcontrols and inspection checks in place.> Responsibilities include First piece qualification process, initiation and review of ECOs, MRBcoordinator, Supplier Scorecards, ISO and AS9100 compliance, collect and analyze customerrepairs data, supplier performance, and internal data for continuous improvement, internalprocess audits, calibration maintenance, and create/maintain a Supplier Manual.> Identify and create process and inspection documentation for manufacturing cells.General Electric - Billerica, MaMay 2003 July 2007(Sensors for food, oil & gas, and water)Supplier Quality Engineer> Drive supplier quality, internal quality and customer quality initiatives. Responsibilities includedriving and performing root cause analysis, implement corrective/preventive action for supplier,internal and customer quality and process issues. Weekly meetings with suppliers and internalmanufacturing managers to review and address manufacturing and quality issues based oncollected yield, defect, repair and warranty return data.> Team with mechanical and electrical manufacturing engineers to drive continuous processimprovements at the supplier and internal operations.> Perform quality/process audits at suppliers and internal operations.> First piece qualification review and validate CTQs and PPAP (Production Part Approval Process)which includes PFMEA, process maps, gauge r & r, quality/process control plans.> Review ECOs as required; represent quality/process engineering at ECO review board meetings.> Supplier/Internal/Customer corrective action coordinator. Lead efforts of Investigation andclosure of all corrective action requests.> Non-conforming material/MRB coordinator.> Support sourcing efforts in transferring products to be manufactured and tested in LCRs (lowcost regions)Lucent Technologies - Westford, MaJanuary 2000 April 2003Supply Quality Engineer> Perform supplier quality, internal quality and customer quality initiatives. Responsibilitiesinclude weekly meetings with suppliers and internal manufacturing managers to review andaddress manufacturing and quality issues based on collected yield, defect, and repair &warranty return data.> Perform quality/process audits at suppliers & internal operations.> Support Life Cycle Management and the Buyer/Planners with product rationalization projects.Ramp up new products to the suppliers and ramp down end of life products.> Drive root cause, and implement corrective/preventive action for supplier, internal andcustomer quality and process issues.Raytheon - Tewksbury, MaOctober 1980 Dec 1999Quality Engineer> Quality data analysis> Readiness Reviews> ECO review> MRB chair> Manufacturing/Test process monitoringEDUCATION:> Attended Fitchburg State College Business Management and Engineering courses> Attended UMass-Lowell Engineering courses> Attended Fisher College Business Management> Attended Nichols College Business ManagementNo degree obtained (Due to the travel demands of my role as a supplier QA engineer, I wasnever able to complete a degree program)Skilled in: Agile, Arena, Oracle, QAD, Microsoft tools, PCB / PCBA / Wire harness, IPC Standards, LeanManufacturing .QSG (Quality Support Group) Training by James F LeonardCertificates in:> Failure Modes and Effects Analysis (FMEA / PFMEA)> Statistical Process Control (SPC) Tools & Concepts> CAPA TOOLS for Effective Problem-SolvingQPS (Quality & Productivity Solutions)Certificate in:> Lean six sigma |
