SUMMARY

• A Senior Principal Quality Engineer/QMS Auditor with experience working with Contract Manufacturing Organizations, OEMs, Distributors, In - Vitro devices, Metal Fabrications, Finished Goods, Raw Materials, Injection Molding & Blow-Fill-Seal technology, Electronics Manufacturing Services (EMS) and Ethylene Oxide/Gamma Radiation sterilization.
• Led and supervised 70 technicians in teh re-manufacturing and servicing of electro-mechanical medical devices.
• Core team member in teh selection, evaluation and qualification process of new critical suppliers.
• Managed Supplier Quality Program (Supplier Corrective Action Requests (SCARs), Nonconforming Reports (NCRs), Customer complaints, External/Internal PPMs, Supplier Rating/Scorecards, Quality Agreements and Supplier Quality Assessment Questionnaires).
• Managed company Internal/External (Supplier) Audit and CAPA Program. Performed Internal/Supplier Quality Management System (QMS) audits based on company SOP’s, standards and regulatory requirements.
• Managed (Chaired) Material Review Board (MRB) to discuss/resolve disposition of nonconforming materials/products.
• Created/established Supplier Quality Agreements for critical outsourced process suppliers (Tier 1 & Tier 2).
• Supported CAPA Remediation process by reviewing retrospective supplier CAPAs for completeness to address CAPA plans, root causes, implemented corrective actions and TEMPeffectiveness checks and utilized Global Supplier Quality TrackWise Systems (GSQTS).
• Led problem-solving efforts with suppliers, including customer complaint investigation and analysis to identify and resolve chronic quality issues to ensure production of TEMPeffective medical devices.
• 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, Customer complaints and provides trend analysis.
• Extensive experience in teh re-manufacturing, servicing, device failure root cause analysis, data analysis/trending of device failures and customer complaints related electro-mechanical medical devices.
• Performed batch documentation reviews, approval and releases of production Device History Records (Batch records) per DMR requirements.
• Coordinated and supervised teh quality incoming, in-process and final inspection activities.
• Experienced in Auditing, Verification & Validation, Risk Management, Lean Management, Production Management, Documentation Control and Quality Engineering in teh medical device and pharmaceutical industry.
• Assigned as QE (Core member) for teh New Product Development (NPD) and function as teh Design Quality Assurance Engineer (Process Flow, DFMEA, PFMEA, Control plans, 8D, Verification/Validation).
• Facilitated weekly Divisional Product Change Control Board.
• Developed/revised Standard Operating Procedures (SOPs), Work Instructions, BOMs, Process Flow Charts, FMEAs, Control Plans and Inspection plans criteria to outline for reference use in blueprints, drawings and specifications.
• Worked with cross functional teams in teh manufacturing setting towards continuous improvements (Kaizen) activities.
• Variation Reduction Kaizen (VRK) with teh objective of scrap reduction, Transactional Process Improvement (TPI) in Warehouse Receiving, 5S (Lean Manufacturing), Standard Work on SelecTech Stains manufacturing to improve efficiency/productivity, Value Analysis/Value Engineering (VA/VE) and Value Stream Mapping (VSM).
• Developed validation documentation (Protocols, IQ, OQ, and PQ Checklists, Validation Final Summary Reports) and executed validation activities (software/hardware) to appropriate regulatory agency validation requirements, internal company procedures and current industry standard practices.
• Knowledgeable in areas of RoHS, PPAP, 21CFR Part 820, ISO 13485, ISO 14971, ISO 9001:2008, ISO 19011, current Good Manufacturing Practices (cGMP), GHTF Guidance documents and IPC-A-610.
• Knowledgeable and experience in areas of Ethylene Oxide & Gamma sterilization, Injection Molding, Blow/Fill/Seal (BFS) Technology, remanufacturing/servicing of electro-mechanical devices and Electronics Contract Manufacturing.

TECHNICAL SKILLS

• Mini-Tab R16
• MS Excel
• Word
• PowerPoint
• Access
• Outlook
• Visio
• MS Project
• Enterprise Resource Planning (ERP)
• SAP
• QuickBase
• Global Supplier Quality Track Wise Systems (GSQTS)
• Lotus Notes.

PROFESSIONAL EXPERIENCE

Confidential, Waukegan, IL

Senior Principal Quality Engineer

Responsibilities:

• Managed teh Supplier CAPA (SCARs) and Internal Audit Program. Maintained supplier audit schedule.
• Performed supplier audits (Lead Auditor) and internal audits.
• Managed teh Material Review Board (MRB) in dispositioning of nonconforming materials/products.
• Led team (Quality, Supply Chain) in teh 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 RMA’s.
• Coordinates with critical and major suppliers in teh resolution of quality issues (electronic components, electro-mechanical assemblies, fabricated metals and outsourced critical services).
• Performed Gage R&R (Repeatability & Reproducibility) on manufacturing processes and revised QMS documents for continual improvements.
• Creates/establishes (on-going) Risk Management process (manufacturing process flow, FMEA & control plans).

Confidential, Arlington Heights, IL

Senior Quality Assurance Engineer / CAPA

Responsibilities:

• Managed teh facility CAPA Program.
• Developed periodic quality metrics (NCRs, complaints, supplier quality & scrap) and ensured that quality data is collected and reviewed for trends to drive continuous improvement.
• Performed supplier audits (Lead Auditor) and internal audits.
• Assisted Facility Safety Manager towards continuous improvement in teh facility Safety program. Performed monthly Environment Health & Safety (EHS) audits.
• Identified and implemented improvements in teh manufacturing process (me.e. Passivation of Stainless Tanks - Surge, Batch and Portable Tanks).
• Trained employees on current Good Manufacturing Practices (cGMP) & Lean process (GDP, 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 records) per DMR requirements.

Confidential, Richmond, IL

Senior Supplier Quality Engineer

Responsibilities:

• Core team member in teh selection, evaluation and qualification process of new 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 SOP’s, 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 TEMPeffective medical devices.
• Increased teh Efficiency & TEMPEffectiveness 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 teh quality incoming, in-process and final inspection activities.
• Assigned as QE (Core member) for teh New Product Development (NPD) and function as teh Design Quality Assurance Engineer (Process Flow, DFMEA, PFMEA, Control plans, Verification/Validation).
• Worked with cross functional teams in teh manufacturing setting towards continuous improvements (Kaizen) activities. Reduction Kaizen (VRK) with teh 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).

Confidential, Lake Forest, IL

Quality Engineer / Global Supplier Quality

Responsibilities:

• Supported CAPA remediation process by reviewing retrospective supplier CAPAs for completeness to address CAPA plans, root causes, implemented corrective actions and TEMPeffectiveness checks per procedural requirements. dis includes assembling teh CAPA and ensuring there is adequate objective evidence to close teh 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 teh 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.

Confidential, McHenry, IL

Supplier Quality Engineer / Validation

Responsibilities:

• Assisted in teh selection, evaluation and qualification of new suppliers.
• Created Quality Agreements for critical outsourced process suppliers. Developed and/or revised internal/external specifications, procedures, Bill of Materials, 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 teh TEMPeffectiveness of teh corrective and preventive actions.
• Coordinated with suppliers in teh 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 supplier’s 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 supplier’s quality system improvements. Assisted suppliers in teh 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).

Confidential, Round Lake, IL

Quality Engineer

Responsibilities:

• Supported teh day-to-day Quality systems operations and projects.
• 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.
• Provided trend analysis on product complaints to Product Improvement team (PIP) and Global Infusion System (GIS) personnel.
• Extensive experience in teh re-manufacturing, servicing, device failure root cause analysis, data analysis/trending of device errors/failures and customer complaints.
• 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). Resolved quality nonconformity and Corrective Action Preventive Action (CAPA) issues.

Confidential, Mundelein, IL

Distribution Supervisor

Responsibilities:

• Led and supervised 70 technicians in teh 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 insure 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&me) per OSHA requirements.

Confidential , Great Lakes, IL

Biomedical Equipment Systems Technician

Responsibilities:

• Head of Technical Library in Biomedical Engineering Shop.
• Responsible for testing, repairs, calibrating and performing periodic and preventative maintenance of medical devices (me.e. IV infusion pumps, defibrillators, electro-surgical machines, patient monitors, blood pressures, centrifuges, x-ray film processors, warmers and ECG machines) and dental equipments in teh Hospital and Branch Clinics.