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Title Senior Quality Engineer, Automotive and Medical Device
Target Location US-IN-Warsaw
Email Available with paid plan
Phone Available with paid plan
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Eric Garrett, Senior Quality EngineerPHONE NUMBER AVAILABLE EMAIL AVAILABLELINKEDIN LINK AVAILABLEProfileCollaborative Quality Engineering professional with extensive experience in medical device and automotive manufacturing. Proficient in Quality Management Systems (QMS), ISO 9001, ISO 13485, and TS16949. Skilled at fostering teamwork among suppliers, sales, engineering, production, and operations. Notable competencies include process optimization, root cause analysis, cross-functional collaboration, supplier quality management, and successful new product launches. If youre seeking a dedicated quality engineer who thrives on process excellence, Im ready to contribute!ExperienceZimmer Biomet, Warsaw, Indiana  August 2023  April 2024 Akkodis Contract  Senior Quality EngineerCompleted daily quality tasks for new ZB acquisition of Cayenne Medical products. Reviewed and updated prints, documents, standards and performed gap assessments to on-board company. PPAPed all existing part numbers brought in house to establish a baseline.Completed NCRs, CAPAs, Supplier Change Notifications and First Articles for any products within Cayenne Medical.Teamed with buyers and suppliers to ensure components and parts met specification.Position ended due to ZB reducing the number of contractors.J&J-DePuy Synthes, Warsaw Indiana  July 2021  June 2023Real Staffing - Contract - July 2021  March 2022 - Supplier Design Quality EngineerCompleted design quality tasks for new hip implant and instrumentation products  Rhythm Hip Project.Conducted special process verifications (PVE), and Level 5 equivalent PPAP for the Rhythm program at the supplier.Wrote PVE Protocols and Reports, took part in design reviews and recommended changes if needed.Presented solutions for design flaws -manufacturability issues, inspection issues and other manufacturing challenges.Performed CTQ reviews, validation reviews at the supplier, MSE activities (GRR), Correlation, capability studies and FAI.Reduction of contractors during Covid.Finished Project.Theoris - Contract - Aug 2022 - Jun 2023 NPI Manufacturing Quality EngineerLaunched new products for NPI Manufacturing. - Ceramic Femoral Heads and Unity PinsConducted IQ, OQ, PQ validation and performed Engineering Studies to set up new processes.Teamed with vendors for PPAP and special process services for projects  Sterilization, etch, blast, coatings etc.Kaizen - led problem investigations, in-depth root cause analysis and corrective action for my areas.Received a one-year extension but the contract ended due to a reduction in force. Completed Ceramic Product Launch.Recovery Force - Full Time, Fishers, Indiana  February 2020  March 2021 Quality EngineerAuthor of new QMS for a new startup company which created the MAC device to manage DVT and circulation problems.Collaborated closely with suppliers in China for PPAP (Jabil and others) to qualify and FAI all components for the MAC device.Maintained Quality metrics for Management Review, NCs, CAPAs, Supplier Quality, Customer Complaints and Delivery.Successful in achieving ISO 13485 registration and passed all audits with no minor or significant issues.Ended due to reduction of employees.Incipio Devices  Full Time, Huntington, Indiana  December 2018  October 2019 Senior Quality EngineerLaunched new products after PPAP approval from provided prints and specifications in ISO 13485 regulated CNC machining environment.Approved outside vendors for special processes including laser etch, heat treat, blast, passivation, polish and coatings.Closed NCRs and CAPAs by conducting thorough problem investigations and correct root cause analysis.Resigned position to care for family member.Gecom Corporation  Full Time, Greensburg, Indiana  October 2017  August 2018 Senior Quality EngineerResolved issues for Chrysler plants in Canada and Mexico for complex electromechanical door, hood and trunk locking mechanisms.Focused on factual problem investigation, in-depth root cause analysis for assembly and fabrication processes.Traveled extensively in Mexico to solve new model problems and supplier quality issues and concerns.Through constant attention to my product lines, I was able to achieve a 97-100% FTPR on all 3 shifts by error proofing the manual assembly processes and automated vision systems to verify proper location during assembly. Re-PPAPed both lines for changes.Changed position due to amount of time (7 months) in Mexico.Garrett Quality Consulting, Muncie, Indiana  February 2014  March 2017 ConsultantProvided Quality Services to World Class companies, managed and mentored 2 Quality Engineers on my team.Adecco, Bloomington, Indiana  August 2016  March 2017 CAPA ConsultantPerformed in-depth assessments of CAPAs. Reviewed, changed and closed CAPAs.Led FDA remediation corrective action closure efforts with a 4-member team. Held team accountable weekly basis.Instructed on root cause identification and methodologies such as Ishakawa Fishbone, 6Ms, 5 whys, RCA, Fault Tree Analysis Engent R+D / Aerotek, Norcross, Georgia  October 2015  April 2016 Quality Consultant, ManagerLed PPAP activities for the Tesla Model S and X LED headlight lines which produced 12,000 units a week.Actively held bi-weekly PPAP meetings with the Program Manager and other key players in Fremont, California on quality issues.Alcon / Astrix Engineering, Johns Creek, Georgia  May 2015  October 2015 ConsultantOrganized and performed a periodic review of IQ, OQ, PQ validation for 33 contact lens manufacturing lines.Space Craft Inc / Sanmina / Allstate Engineering, Huntsville, Alabama - February 2013  January 2015 ConsultantServed as Quality Engineer for New Product Introductions and PAPP for Philips Ultrasound, CRISI, Bosch, Stryker, Coke and US ARMY.Specd, constructed and certified a new Class 10,000 clean room for CRISI (later sold to BD) for assembly of an injection port device.Wrote all clean room procedures per ISO 14644 requirements.Tridien Medical, Fishers, Indiana - March 2011  January 2013 Senior Quality Engineer.Built the QMS for manufacture and assembly of medical beds for Stryker and Hill Rom and achieved BSI certification in 6 months.Opened and closed NCRs, corrective actions, managed calibration system, validation, receiving inspection, and managed 4 Inspectors. Tridien startup location closed due to corporate capital issues.King Systems Corporation, Noblesville, Indiana - March 2009  January 2011 Senior Quality EngineerValidated processes for molded and extruded laryngeal airways, anesthesia ventilation filters, optical laryngoscopes, and masks.Responded to customer complaints, internal issues per NCR process and led Corrective Action investigations to closure.PPAPed multiple new devices - fruit scented King Pediatric Anesthesia Masks, King Vision Optical Laryngoscope, King LTSD Intubation Airway and several anesthesia filters with partnered suppliers in New Hampshire, Shanghai and Kunshan, China.Got Six Sigma Greenbelt at King Systems  Lean Manufacturing / Waste Reduction project saved $281,000.Position ended due to Consort Medical acquisition and then sold to AMBU.Darnell Army Medical Center, Fort Hood, Texas - July 2005  December 2008 X-Ray TechnicianObtained X-Ray images for soldiers primarily in the burn (trauma) unit, honored with Darnell Achievement Coin for proficiency of tasks. Served for 2 deployments, consecutively.United Technologies - Carrier, Indianapolis, Indiana - May 2003  May 2005 Quality EngineerLaunched two new furnace lines, International Comfort Products, which each produced 2,000 furnaces per day.Performed Minitab capability studies on critical dimensions. Specified / Ordered gages for CTQs. Captured in GageTrack SoftwareUsed quality tools such as PPAP, SPC, Fishbone Diagram, 5 Why, 6Ms and Carrier Certification to drive process improvement.Saved the company a generous sum of money by reducing scrap. Total saved during career at UT  $332,000.Plant moved to Leon, Mexico.Guide - General Motors, Anderson, Indiana - July 1998  February 2003 Manufacturing Engineer IIIProvided 4 color taillight injection molding and tooling support for 13 Krauss Maffei machines I was responsible for.Programmed FANUC robots and reset faults, diagnosed problems with tools and 4 color molding machines.While monitoring my processes, the focus was on scrap prevention and decreased multicolor scrap by 35% over a 2-year period.Managed Preventative Maintenance efforts and upgrade projects saving GM a total of $1.6 million, year over year.Plant moved to Monterrey, MexicoEducation:Ball State University  Muncie, Indiana  Bachelor of Science, Industrial Engineering TechnologyUS Army Signal Corp  Fort Gordon, Georgia  Electronic Technician 29JUS Army Academy of Health Science  Fort Sam Houston, Texas - X-Ray Technician 68P / Surgeon General Proficiency AwardIvy Tech Muncie, Indiana  Emergency Medical Technician  EMT CertificationCertification:American Society for Quality  Chicago, Illinois  ISO Implementation and Auditing CertificationKing Systems  Noblesville, Indiana  Six Sigma Green Belt - Lean Manufacturing / Waste Reduction totaled $282,000.00.BSI - British Standards Institution - Auburn, Alabama - TS  16949 Automotive Auditing Certification

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