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(Cell) PHONE NUMBER AVAILABLE; (Home) PHONE NUMBER AVAILABLEEmail: EMAIL AVAILABLEExecutive Summary: A Quality Professional subject matter expert working in a highly regulated industry (FDA) with exposures to OEMs and Contract Manufacturing Organizations (CMOs) in areas of Medical Device Assembly & Finished Goods, In- Vitro devices (IVDs), Medical Device electro-mechanical repairs/remanufacturing, SMT Electronics Manufacturing Services (EMS), Plastic Injection Molding & Blow-Fill-Seal technology, Swiss & CNC Machining, Metal stamping, welding, Ethylene Oxide/Gamma Radiation sterilization and Medical Laboratory Technology environment. Experienced in Auditing, Verification & Validation, Risk Management, Lean Management, Design Control, Documentation Control, Purchasing Controls, Corrective Action/Preventive Action (CAPA), Non-Conformance and Production & Process Control in the medical device and pharmaceutical industry. Expertise in areas of FDA 21CFR820, EU MDR 2017/745, ISO 13485, ISO 14971, ISO 9000, ISO 19011, ISO 10993 Parts 1, 3, 5 & 12, RoHS2, REACH, Conflict of Minerals, PPAP, SDLC/SDM, cGMP/GLP/GDP, GD&T, IPC-A-610 Electronics Assembly acceptance criteria, Team Centered Unified (TcU) - Siemens Product Life Cycle Management (PLCM).Educations:Massachusetts Institute of Technology (MIT), Cambridge, MA Professional Certificate Program in Architecture and Systems Engineering Southern Illinois University (SIU), Carbondale, IL BS in Electronics ManagementUniversity of San Carlos (USC), Cebu, PhilippinesBS in Electronics and Communications EngineeringMilwaukee School of Engineering (MSOE), Milwaukee, WI Graduate Certificate Program in Quality, completed in August 2003. Earned 18.0 credit hours College of Lake County (CLC), Grayslake, ILEssentials and Advanced Project Management on March 2013. Villanova University, Villanova, PACertificate in Six Sigma Green Belt on Nov 2010Certifications:ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE) ASQ Certified Quality Engineer (CQE)ASQ Certified Quality Auditor (CQA)ASQ Certified Calibration Technician (CCT)ASQ Certified Six Sigma Green Belt (CSSGB)ASQ Certified Quality Technician (CQT)ASQ Certified Quality Inspector (CQI)ASQ Certified Quality Improvement Associate (CQIA) Professional Experiences:Abbvie (Contract), North Chicago, IL 4/2023 6/2023 Engineer IV (Reason for leaving: Ended contract due to emergency that requires overseas travel and longer stay) Performed Verification and Reliability testing on medical device (Infusion System). Identified/outsourced supplier on building custom test equipment to support R&D operations. Reviewed newly identified Contract Manufacturers processes (Product Risk Assessment, Process Flow, DFMEA, PFMEAs, Control Plan, SOPs, Work Instructions and ESD Program). Led/coordinated with teams globally (manufacturer, internal customers, Design Engineers, transportation and Custom brokerage) in the shipment of Reliability Test equipments to United States. HCL America Solutions Inc. (client: Baxter Healthcare), Deerfield, IL 2/2022 4/2023 Associate Manager / Quality Pre-Clinical (Contract) Collaborated with Research Scientists globally (US, Belgium, Malta, India, China and Japan) in the Preclinical Biocompatibility arena for the development of new and sustaining products to ensure safety and efficacy of medical devices are met per EU/MDR 2017/745 requirements. Worked with external network of suppliers in conducting nonclinical safety, biocompatibility and efficacy of Extractable and Leachable Studies (E&L studies). Processed devices, components, assemblies for external suppliers to perform biological and chemical testing. Performed final reviews and verifications on Toxicological Risk Assessments (TRAs). Acted as a Study Director in generating Study Plans, Material Specifications (MATs) and Material Assessments through Product Lifecycle Management System (Team Center Unified). Performed feasibility/simulation testing of product reliability and functionality adhering to Good Laboratory Practices.A L Hansen Manufacturing Co., Waukegan, IL 10/2021 12/2021 Plant Quality Manager (60-Day Contract) Responsible for direct supervision of QA personnel and the development of skills required to support present and future business objectives. Ensures an ISO 9001:2015 compliant quality management system and provided required customer certifications(RoHS, REACH & Conflict Minerals) requests. Managed customer engagement for customer quality product complaints, returns and new product development projects. Recommended continual improvements on quality inspections, testing/production methods and equipments to ensure compliance with customer and industry standards. Managed the Supplier Quality program (Approved Supplier Lists, Supplier/Internal CAPAs). Managed the weekly Material Review Board (MRB) for the dispositioning on product nonconformances. Foxconn Industrial Internet, Mount Pleasant, WI 6/2020 4/2021 Quality Engineering Supervisor Managed the Supplier Quality Program (supplier selection, evaluation, qualification, approval and monitoring) with two (2) Supplier Quality Engineers (Direct Reports) and Incoming Quality Inspection with two (2) Senior Quality Technicians (Direct Reports). Managed the Quality In-Process manufacturing activities with two (2) Quality Engineers (Direct Reports) in the performance of Statistical Process Controls, Process Validation, Measurement Systems Analysis (Gage R&R), Process Flows, PFMEAs, Control Plans, Capability Studies, NCMRs and CAPAs. Managed the Calibration Programs with two (2) Calibration Technicians (Direct Reports). Developed/established (on-going) Quality Management Systems in obtaining ISO 13485 certification for a start-up company. Managed various projects assigned by the executive management team (New Product Introduction). Led Kaizen continuous improvements initiatives (Warehouse, Incoming Quality Inspection) leading towards productivity, efficiencies and scrap reductions. Managed Material Review Board (MRB) for dispositioning of nonconforming materials and CAPA program. Managed/facilitated execution of Validation programs for newly installed equipments and processes. Assisted in hiring and training of department staffs. Viant Medical, Wheeling, IL 10/2018 3/2020Senior Quality Engineer Sustaining & NPI (Reason for leaving: Company-wide layoffs) Senior level Quality Engineer in managing the two (2) facilities Quality program activities and NPI projects. Managed the Material Review Board (MRB) for the dispositioning (RTV, Use-As-Is, Scrap & Rework) of nonconforming parts/raw materials/finished goods and new development products. Supported New Product Developments in developing and executing process validation protocols and published reports. Developed/revised process flow, PFMEAs and control plans and performed Capability Studies (Cps, Cpks) and Gage R&R studies. Revised/developed quality system documents (procedures, work instructions, inspection plans, PFMEA, control plans) through Engineering Change Request (ECR) or Document Change Order (DCO) to improve production processes as part of continual improvements. Responsible for the Supplier Quality Program. Tracking of supplier nonconformance, issuing SCARs (supplier CAPA), corrective & preventative action implementation, effectiveness checks, review & closure. Responsible for Customer product complaints in providing identification of root cause, corrections, corrective & preventative action implementations and effectiveness checks. Issued product Quality Alerts (QA) to production. Developed cost reduction programs to achieve corporate goals. Issued Temporary Deviation Reports (TDRs) for product deviating from meeting requirements with internal and customer approvals. Performed monthly Environment Health & Safety (EHS) internal audits. Flex, Buffalo Grove, IL 3/2018 10/2018Senior Quality Engineer / Software Validation (Reason for leaving: Added overseas travel requirements) Lead QE for the two Junior QEs in the development of Master Validation Program (MVP, Protocol development, IQ, OQ & PQ) for the new project with planned 54 Injection Molding Machines (IMMs) installation. Lead QE/Quality Department Representative in the development of electronic Device History Record (eDHR). Developed Business Requirement Development (BRD), Functional Requirement Specification (FRS), User Requirement Specifications (URS) or Test Scenarios and Test Cases for the eDHR. Participated with the Global IT team in the prototype system to ensure quality requirements are included in the design, development and implementation of the eDHR for injection molding, surface mount technology (SMT) and automation. Performed the execution of corporate eDHR software validation to include site level software validation. Established AQL sampling plans for the injection molding validation activity. Worked with Process Engineers (Molding) in process flow creation, led team in the PFMEA creation. BioTelemetry, Inc., formerly LifeWatch Services, Inc. (via Aerotek), Rosemont, IL 7/2017 03/2018 Quality Engineer Consultant (Contract) Managed/established on-going Process Validation program (Master Validation Plan, Protocol development, IQ, OQ, PQ, Final Report) for the newly installed Numina Voice Directed Order Fulfillment System to increase order throughput, lower labor costs, improve kit, order accuracy and integrate quality into the process. Developed training program and trained facility personnel on process validation, cGDP and nonconformance process. Reviewed and approved newly created Device Master Records (DMRs) and Bill of Materials (BOMs) for the newly installed assembly devices/kits process. Identified deficiency in Quality Management Systems through careful review (audit) and implemented a permanent corrective action (i.e. Acceptance activities developed Work Instructions/Quality Forms for existing Incoming Inspection and Finished Device Final QC Inspection and for new Voice Directed Order Fulfillment system. Assigned by VP of Global Quality & Compliance to manage the Quality Control team of four (4) QC Technicians. Reduced product nonconformance issues to 80% by implementing continual improvement to production process. Established Internal Audit Program and scheduled Annual Supplier Audits. Performed inter-departmental internal audits.Tecnova Electronics, Inc., Waukegan, IL. 7/2016 5/2017 Senior Principal Quality Engineer (Reason for leaving: Company-wide layoffs) Managed the Supplier CAPA (SCARs) and Internal Audit Program. Maintained supplier audit schedule. Performed supplier audits (Lead Auditor) and internal audits. Managed the Material Review Board (MRB) in dispositioning of nonconforming (NCR) materials/products. Led team (Quality, Supply Chain) in the selection, evaluation, qualification and approval of new suppliers. Performed investigation, resolution and trending of customer complaint issues. Established Supplier/Customer Quality agreements, Non-Disclosures agreements and coordinates with Supply Chain Buyers in processing RMAs. Coordinates with critical and major suppliers in the resolution of quality issues (electronic components, electro- mechanical assemblies, fabricated metals and outsourced critical services). Managed the facility Calibration Program. Performed Measurement Systems Analysis (Gage R&R) on manufacturing processes. Revised QMS documents for continual improvements. Implemented Dock-To-Stock (DTS) program. Created/established (on-going) Risk Management process (manufacturing Process Flow, FMEA & Control Plans). Coordinated with suppliers to ensure parts/items/components received meets RoHS2 requirement. Operates X-Ray Machine (Nikon XTV130) on Ball Grid Array (BGA) analysis (voids, shorts/bridges, size/volume, etc.)Teleflex Medical Inc., Arlington Heights, IL 11/2015 7/2016 Senior Quality Assurance Engineer / CAPA (Reason for leaving: Added overseas travel requirements) Managed the facility CAPA Program. Developed periodic quality metrics (NCRs, complaints, supplier quality & scrap) and ensured that quality data was collected and reviewed for trends to drive continual improvements. Performed supplier audits (Lead Auditor) and internal audits. Assisted Facility Safety Manager towards continuous improvement in the facility Safety program. Performed monthly Environment Health & Safety (EHS) audits. Identified and implemented process improvements in the manufacturing process (i.e. Passivation of Stainless Tanks - Surge, Batch and Portable Tanks). Trained employees on current Good Manufacturing Practices (cGMP/GDP) & Lean process (5S). Trending of customer complaints and manufacturing quality issues, investigation and resolution of issues. Performed health hazard evaluation (HHE), risk assessment and Observation Reports. Performed batch documentation reviews, approval and releases of production Device History Records(Batch/Production records) per DMR requirements.Leica Biosystems (A Danaher Company), Richmond, IL 1/2014 11/2015 Senior Supplier Quality Engineer (Reason for leaving: Travel requirements not feasible anymore) Led the selection, evaluation and qualification process of new critical suppliers. Managed (Chaired) Material Review Board (MRB) to discuss/resolve disposition of nonconforming materials/products. Managed Supplier Quality Program (SCARs, NCRs, Customer complaints, External/Internal PPM, Supplier Scorecards, Quality Agreements and Supplier Quality System/Assessment Questionnaires). Managed company internal and suppliers audit program. Performed internal/supplier Quality Management System (QMS) audits based on company SOPs, standards (ISO 13485) and regulatory requirements (21CFR 820). Led problem-solving efforts with suppliers, including customer complaint investigation and analysis to identify and resolve chronic quality issues to ensure production of effective medical devices. Increased the Efficiency & Effectiveness of Corrective Actions by adding controls to External (Supplier) Processes. Developed/revised Standard Operating Procedures (SOPs), Work Instructions (WIs) and Incoming Inspection plans for reference use in blueprints/drawings, inspections and specifications. Coordinated and supervised the quality incoming, in-process and final inspection activities. Managed the facility Calibration Program. Acted as Design Quality Assurance Engineer for New Product Development (Input/Output requirements, Process Flow, DFMEA, PFMEA, Control plans, Verification/Validation) per Design Control requirements. Worked with cross-functional teams in the manufacturing towards continuous improvements (KAIZEN) activities. Reduction Kaizen (VRK) with the objective of scrap reduction, Transactional Process Improvement (TPI) in Warehouse Receiving, 5S (Lean Manufacturing), Standard Work on SelecTech Stains manufacturing to improve efficiency and productivity, Value Analysis/Value Engineering (VA/VE) and Value Stream Mapping (VSM). Hospira, Inc. (via Kelly Services), Lake Forest, IL 8/2013 -12/2013 Global Supplier Quality Engineer (Contract) Supported CAPA Remediation process by reviewing retrospective supplier CAPAs for completeness to address CAPA plans, root cause identification, implemented corrective actions and effectiveness checks and utilized Global Supplier Quality TrackWise Systems (GSQTS) for documentations. This includes assembling the CAPA and ensuring there was adequate objective evidence to close the CAPA while tracking to completion. Reviewed Audit Schedule tracker for accuracy and completeness. Escalated issues and roadblocks to management and provided solutions. Assisted Global Supplier Quality (GSQ) in the preparation of NSAI audits by reviewing, identifying Device critical components and sending Critical Component Notification Letters to suppliers and ensuring current Risk Assessments and Quality Agreements are established. Medela, Inc., McHenry, IL 3/2011 - 8/2013Supplier Quality Engineer / Validation Collaborated with SCM and NPI in the selection, evaluation and qualification of new suppliers. Created Quality Agreements for critical outsourced process suppliers. Developed and revised specifications, SOP procedures, Bill of Materials (BOM), process flow and control plans for continual improvements. Evaluated and analyzed process control quality data from supplier and evaluated for any improvement opportunities. Reviewed and analyzed supplier related nonconforming products through product Nonconformance Reports(NCRs). Issued Supplier Corrective Action Requests (SCAR), reviewed and approved corrective action responses for closure, trended and monitored appropriate indicators to determine the effectiveness of the corrective and preventive actions. Coordinated with suppliers in the implementation of necessary supplier Corrective Action Preventive Action(CAPA) through SCAR process to ensure compliance to specified procedures, industry standards and regulations. Monitored, measured and maintained multiple suppliers performance (Tier 1 & sub-tier) through quality metrics and provided quarterly supplier/vendor performance score cards. Implemented Dock-to-Stock program. Performed on-site supplier audits and reviewed 3rd party audit reports for issuance of supplier CAPA. Provided support to suppliers quality system improvements. Assisted suppliers in the implementation and performance of process validation activities. Managed internal/external supplier quality related projects. Participated in Material Review Board (MRB) to discuss/resolve disposition of nonconforming materials/products. Developed validation documentation (Protocols, IQ, OQ, and PQ Checklists, Validation Final Reports) and executed validation activities (software/hardware) to appropriate regulatory agency validation requirements, internal company procedures and current industry standards and practices. Compiled validation data through measurement and inspection, supporting validation reporting, made recommendations for changes and/or improvements and investigate/troubleshoot problems and suggested for solutions. Performed Design of Experiments (DOE) and developed work instructions (WI). Provided Support to Regulatory Affairs function in the 510K submission. Field Associate, Independent Contractor, Lindenhurst, IL 2/2007 - 12/2010 Conducted interior/exterior inspections, recommended repairs and provided estimates (repairs) on real estate properties for lenders. Provided property valuation for bank-owned properties to lenders. Baxter Healthcare Corporation, Round Lake, IL 1/2005 - 10/2006 Senior Quality Engineer Supported the day-to-day Quality management systems operations and projects. Facilitated weekly Divisional Product Change Control Board. Reviewed and analyzed data from various sources including but not limited to Non-Conformances, Field Corrective Action (FCA), Medical Device Recall (MDR), Service Report data and Customer complaints and provided trend analysis. Provided trend analysis on product complaints to Product Improvement team (PIP) and Global Infusion System(GIS) personnel. Extensive experience in the re-manufacturing, servicing, device failure root cause analysis, data analysis/trending of device failures and customer complaints related electro-mechanical medical devices. Reviewed and approved various Product Development documents such as Engineering Change Requests(ECRs), protocols, design reviews, verification & validation (V&V) reports. Reviewed document revisions and specifications as part of quality systems or product improvements. Supported product Mold Projects. Performed projects in-process audits on Design History Files (DHF) per Design Control requirements. Resolved quality nonconformance and Corrective Action Preventive Action (CAPA) issues. Baxter Healthcare Corporation, Mundelein, IL 4/2000 - 12/2004 Distribution Supervisor (Operations) Led and supervised 70 technicians in the Refurbishment shop and 36 technicians in Repair shop for Infusion Volumetric (IV) pumps (Colleague, Flo-Gard and AS40). Oversaw refurbishment/repair operations, productivity and quality. Monitored proper documentation to ensure compliance with standard Good Documentation Practices (GDP). Enforced company policy, conducted new hires orientation, trained technicians on procedures and annual EHS requirements (Blood Borne Pathogens, Safety training). Changed or revised procedures as part of continual improvement process. Assisted EHS Manager in Environment Health and Safety (EHS) activities. Audit Team Leader in conducting Quarterly EHS facility audits. Maintained, updated and trained facility personnel on Material Safety Data Sheet (MSDS) changes. Responsible for reporting Occupational Illness & Injury (OI&I) per OSHA requirements. Additional Professional Training: Certified IPC-A-610 Specialist (CIS) Acceptance Criteria for Electronics Assemblies Completed 36-Hour of ISO 13485 & 9001:2008 Lead Auditor Training, June 2011 Supplier Management, Regulatory Affairs Professionals Society (RAPS), March 2015 Process Validation for Medical Device from ASQ, November 2012 Variation Reduction Kaizen (VRK), Standard Work (SW), Transactional Process Improvement (TPI) Value Analysis/Value Engineering (VA/VE) Kaizen, Value Stream Mapping (VSM) Shingijutsu (New Technology) Shin Kaizen, February 2014 & May 2015 Software Development Life Cycle (SDLC), Agile Development Model, Software Quality Assurance/Testing Professional Affiliations: Senior member of the American Society for Quality (ASQ) since 2003. Member (previous) of the Regulatory Affairs Professionals Society (RAPS). Member (previous) of Association Connecting Electronics Industries (IPC). Served the United States Navy and Naval Reserve. |
