Edgar S. Ratilla

*** ********** ******, ***********, ******** 60046

(Home) 847-***-****; (Cell) 847-***-****

Email: addgkj@r.postjobfree.com

Executive Summary:

A senior level Quality Engineer/QMS Auditor with experience working with OEM Manufacturing and Contract Manufacturing Organizations (CMOs) in areas of In-Vitro devices, Injection Molding & Blow-Fill-Seal technology, Swiss & CNC Machining, SMT Electronics Manufacturing Services (EMS), Medical Device Repairs/Remanufacturing, Packaging, Electro-mechanical Finished Goods (FG) medical devices and Ethylene Oxide/Gamma Radiation sterilization for twenty (20 years) in the highly regulated FDA medical device industry.

Supervised 70 technicians for five (5) years in the re-manufacturing (refurbishment) and servicing of electro-mechanical finished goods medical devices.

Managed the facility Corrective Action/Preventive Action (CAPA) and Calibration Program.

Managed Supplier Quality Program (Supplier Corrective Action Requests (SCARs), Nonconforming Reports (NCRs), customer product complaints, External/Internal PPMs, Supplier Rating/Scorecards, established Supplier Quality Agreements and Supplier Quality Assessment Questionnaires to critical outsourced process suppliers).

Managed company Internal/External (Supplier) Audit Program. Performed Internal/Supplier Quality Management System (QMS) audits based on company SOP’s, standards and regulatory requirements.

Managed Material Review Board (MRB) to discuss/resolve disposition of nonconforming materials/products.

Reduced Incoming inspection (Appraisal) activities by 25% with the implementation of Dock-To-Stock (DTS) program to high performing vendors.

Reduced product nonconformance issues to 80% by implementing continual improvement to production process.

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.

Lead QE in the development of electronic Device History Record (eDHR) and established Business Requirement Development (BRD), Functional Requirement Specs (FRS), User Requirement Specs (URS), Test Scenarios and Test Cases. Collaborated with the Global IT team in the prototype system to ensure quality requirements are included in the design, development and testing of the eDHR for the injection molding process. Performed the execution of corporate eDHR Software Validation to include site level software validation.

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 procedures and current industry standard practices.

Experienced in Auditing, Verification & Validation, Risk Management, Lean Management, Production Management, Documentation Control and Quality Engineering in the medical device and pharmaceutical industry.

Collaborated and supported the New Product Introduction (NPD) team in the creation of Process Flow, PFMEA, Control plans, Process Validation, Measurement Systems Analysis (GR&R) for new customers.

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 the manufacturing towards Continuous improvements (KAIZEN) leading to 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.

Knowledgeable in areas of FDA 21CFR Part 820, RoHS2/REACH, PPAP, ISO 13485, ISO 14971, ISO 9001, ISO 19011, SDLC/SDM, current Good Manufacturing Practices (cGMP), GD&T and IPC-A-610 Electronics Assembly acceptance.

Educational:

Massachusetts Institute of Technology (MIT), Cambridge, MA

Professional Certificate Program in Architecture and Systems Engineering, earned 6.5 CEUs (3 courses), August 2017

Southern Illinois University (SIU), Carbondale, IL

BS in Electronics Management

University of San Carlos (USC), Cebu, Philippines

BS in Electronics and Communications Engineering

Milwaukee School of Engineering (MSOE), Milwaukee, WI

Graduate Certificate Program in Quality, completed on August 2003. Earned 18.0 credit hours.

Naval School of Health Sciences (NSHS), San Diego, CA

Advanced Medical Laboratory Technology School

College of Lake County (CLC), Grayslake, IL

Essentials and Advanced Project Management on March 2013.

Villanova University, Villanova, PA

Certificate in “Six Sigma Green Belt” on Nov 2010

Certifications & Professional Training:

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)

Certified IPC-A-610 Specialist (CIS) – Acceptance Criteria for Electronics Assemblies

Successfully completed 36-Hour of ISO 13485 & 9001:2008 Lead Auditor Training, June 2011

Supplier Management, Regulatory Affairs Professionals Society (RAPS), March 2015

PFMEA/DFMEA, Mistake-Proofing, Kaizen, 5S Process, Gage R&R, Supplier Quality & PPAP from ASQ, March 2012

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

Computer Skills:

Mini-Tab R17/18, Word/Excel/PowerPoint, Outlook, Visio, Oracle, MS Project, SAP ERP, Intuitive iERP, QuickBase, SharePoint, TrackWise Systems (QTS) and Lotus Notes.

SDLC Tools:

JIRA, HP Application Lifecycle Management (ALM), TestRail, TestLodge, Confluence, LucidChart, SQL (Basic)

Professional Experiences:

Viant Medical, Wheeling, IL 10/2018 – 1/31/2020

Senior Quality Engineer - Sustaining & New Product Introduction (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 (Cp’s, Cpk’s) 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 – 10/2018

Senior 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. (contract via Aerotek), Rosemont, IL 7/2017 – 03/2018

Quality Engineer - Consultant

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. (Electronics Contract Manufacturing), 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 RMA’s.

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

Managed the 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 the facility Safety program. Performed monthly Environment Health & Safety (EHS) audits.

Identified and implemented 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 records) per DMR requirements.

Leica Biosystems (A Danaher Company), Richmond, IL 1/2014 – 11/2015

Senior Supplier Quality Engineer

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 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 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.

Assigned as QE (Core member) for the New Product Development (NPD) and function as the Design Quality Assurance Engineer (Process Flow, DFMEA, PFMEA, Control plans, Verification/Validation).

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. (contract via Kelly Services), Lake Forest, IL 8/2013 -12/2013

Global Supplier Quality Engineer

Supported CAPA Remediation process by reviewing retrospective supplier CAPAs for completeness to address CAPA plans, root causes, implemented corrective actions and effectiveness checks and utilized Global Supplier Quality TrackWise Systems (GSQTS) for documentations. This includes assembling the CAPA and ensuring there is 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 - 8/2013

Supplier 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 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 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).

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 for lenders.

Baxter Healthcare Corporation, Round Lake, IL 1/2005 - 10/2006

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). Resolved quality nonconformity 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 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&I) per OSHA requirement

Dade Behring (acquired by Baxter Healthcare Corporation), Mundelein, IL 8/1999 - 4/2000

Biomedical Repair Technician

Repaired, upgraded and tested IV (Infusion Volumetric) pumps using diagnostic processes. Evaluated test data, prepared Shop’s Service Report (SSR) and Cost Estimate. Led five (5) technicians in Wave Shop.

Naval Hospital (Department of Defense), Great Lakes, IL 2/1998 - 7/1999

Biomedical Equipment Systems Technician (US Navy)

Head of Technical Library in Biomedical Engineering Shop.

Responsible for testing, repairs, calibrating and performing periodic and preventative maintenance of medical devices (i.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 the Hospital and Branch Clinics.

Naval Hospital (Department of Defense), Great Lakes, IL 6/1995 - 2/1998

Advanced Medical Laboratory Technologist (US Navy)

Head of Accessioning Section in the Medical Laboratory Department. Performed testing in various clinical laboratory settings (Clinical Chemistry, Hematology, Microbiology and Blood Bank) and ensure adhering to Good Laboratory Practices (GLP) and Good Clinical Practices (GCP).

HIV Coordinator of the Hospital, Branch clinics and Midwest Armed Forces Reserves clinics.

Supervised and trained new personnel in the performance of laboratory procedures, i.e. operation of clinical chemistry, automated immunoassay analyzer, therapeutic drug monitor and blood gas analyzer.

Performed routine scheduled maintenance on laboratory equipment (Clinical Assay Analyzer, Immunoassay analyze

USS Camden AOE-2 (US Department of Defense), Bremerton, WA 2/1990 - 9/1993

Electrical Engineering Technician (US Navy)

Operated standard test and metering instruments, maintained shipboard power and lighting circuits, service and troubleshoot motors, generators, controllers, elevators, switchboards, forklifts and voltage regulators.

Reads and interprets schematic diagram and electrical blueprints. Ship’s Command Lock-out/Tag-out Coordinator.

Professional Affiliations:

Senior member of the American Society for Quality (ASQ).

Member (previous) of the Regulatory Affairs Professionals Society (RAPS).

Member (previous) of Association Connecting Electronics Industries (IPC).

Served the United States Navy for 10 years (Active Duty) and 2 years Naval Reserve.

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