JULIE A. HARRELL
Huntington,USA
Summary
Dynamic Quality Engineer with extensive experience at Tecomet, adept at managing CAPA processes and enhancing product quality. Proficient in PCDMIS programming and internal auditing, I excel in problem-solving and developing inspection criteria, ensuring compliance and customer satisfaction. Recognized for driving continuous improvement initiatives and achieving high-quality standards.
Overview
32
32
years of professional experience
Work History
Quality Engineer
Ultra Maritime
Columbia City, Indiana
03.2024 - Current
- Coordinated solder training programs for production operators.
- Certified trainer for IPC-J-STD-001 standards, delivering training sessions for production staff.
- Certified trainer of IPC A610
- Created certificates of conformance for all out-going audio products
- Trained production operators to solder to the requirements of IPC-J-STD-001
- Created alerts to product quality issues.
- Approved work instructions used by production operators
- Ultra Maritime manufactures buoys that are used in anti-submarine warfare. Ultra Maritime also manufactures powerful speakers that are used for public address and emergency alerts.
Quality Engineer
Incipio Devices
Huntington, Indiana
12.2018 - 03.2024
- New product introduction
- Create inspection criteria
- Review in-coming material
- Review shipping paperwork
- Train operators on inspection techniques
- Incipio Devices manufactures orthopedic surgical instruments and implants for several major orthopedic companies.
Quality Engineer
L.H. Medical
Fort Wayne, IN
09.2017 - 12.2018
- Responsible for creating inspection instructions for new and legacy products
- Created control plans.
- Created PFMEAs
- Preformed product inspection.
- L.H. Medical manufactures orthopedic surgical instruments and implants for several major orthopedic companies.
Quality Engineer
Tecomet (formerly Symmetry Medical)
Warsaw, IN
10.2012 - 09.2017
- Responsible for quality activities of a wide variety of instruments
- MRB-dispositioned non-conforming products and authored re-work procedures.
- Successfully managing CAPA- answering all NCRs from customers for returned parts and internal corrective actions.
- Active in New Product Qualification- set up first article dimensional layouts, created dimension check sheets for quality auditors and operations, performed GR&Rs, performed capability studies, prepared capability data for submission to customer using Minitab as well as worked with customers to clarify part prints and inspection requirements.
- Key person of contact for customers. Listened to and resolved customer concerns. Worked to maintain customer satisfaction.
- Tecomet manufactures orthopedic surgical instruments for all of the major orthopedic companies.
Quality Engineer
NGInstruments
Warsaw, IN
02.2012 - 10.2012
- Resolved customer CAPA requests and complaints to enhance service quality.
- Executed quality activities linked to new product launches, ensuring compliance.
- Addressed customer complaints regarding CAPA requests to improve satisfaction levels.
Quality Engineer
Paragon Medical OMC
Indianapolis, IN
01.2011 - 02.2012
- Logged and addressed customer CAPAs and complaints for effective resolution.
- Managed containment activities and directed disposition of returned products.
- Conducted internal audits for facility compliance, achieving a 91% score on final BSI test.
- Issued CAPAs to suppliers and monitored for timely responses.
- Oversaw quality activities related to new product launches.
- Paragon Medical OMC manufactures orthopedic surgical implants for all of the major orthopedic companies.
Quality Engineer
Symmetry Medical UltreXX
Avilla, IN
06.2005 - 12.2010
- Responsible for quality activities of all instruments and implants
- MRB-dispositioned non-conforming products and authored re-work procedures.
- Successfully managing CAPA- answering all NCRs from customers for returned parts and internal corrective actions.
- Active in New Product Qualification- set up first article dimensional layouts, created dimension check sheets for quality auditors and operations, performed GR&Rs, performed capability studies, prepared capability data for submission to customer using Minitab as well as worked with customers to clarify part prints and inspection requirements.
- Key person of contact for supplier quality- Issued non-conformance reports with vendors. Issued CAPAs to vendors. Active in the assessment and selection of new suppliers. In daily contact with quality auditors responsible for identifying possible quality problems with supplied material. Issued charge backs to vendors for non-conforming products.
- Assisted engineers across disciplines with various projects, database management, and process/product failure analysis as needed.
- Symmetry Medical manufactures orthopedic surgical implants and instruments for all of the major orthopedic companies.
CMM Programmer
Meridian Automotive Systems
Grabill, IN
11.2004 - 05.2005
- Wrote several programs for product launches.
- Ran and improved programs written by other people.
- Performed layouts of gages for certification.
- Wrote programs using math data (CAD).
- Proficient in PCDMIS.
- Meridian Automotive Systems manufactures molded & machined car body panels to all of the major automotive companies.
Metallurgical Laboratory Technician (Temporary Position)
Karl Schmidt Unisia, Inc.
Fort Wayne, IN
09.2004 - 11.2004
- Photograph and document markings of pistons supplied for testing.
- Measured piston dimensions using Mahr, Hiedenhan and Mitutoyo equipment then generated and edited test reports.
- Cut and polish piston sections for hardness testing using a Wilson hardness tester.
- Perform Zyglo inspection to detect cracks.
- Karl Schmidt Unisia supplies pistons for cars, heavy trucks and motorcycles.
Quality Engineer
Schnipke Engraving Company
Ottoville, Ohio
04.2002 - 06.2004
- Responsible for the programming and operation of an LK CMM using DMIS software as well as an OGP SmartScope (optical CMM).
- Report directly to Quality Manager and was his stand-in when out.
- Prepared first article qualification packages to be sent to customers.
- Wrote control plans, process maps and PFEMA’s as well as QC work instructions as well as trained and supervised a staff of 2 technicians.
- Schnipke manufactures injection molded plastic medical components used in endo-surgical procedures & hearing aid parts.
Quality Associate
Wabash Control Products Group
Wabash, Indiana
07.2000 - 04.2002
- Responsible for performing dimensional layouts, Gage Calibration, and other test and metrology activities.
- Programmed and operates a Coordinate Measuring Machine using Metromec software.
- Performed tear-down and analysis of customer returns.
- Assisted in preparations for the ISO-9000 audit.
- Performed gage R&Rs and manage the GR&R recall database.
- Put together PPAP packages.
- Updated Process Control Charts.
- Division responsible for manufacturing sensors used in cars, farm vehicles, sprinkler systems & washing machines.
Quality Technician
Wabash Technologies (Wabash Optek)
Wabash, Indiana
05.1994 - 04.2002
- Wabash Technologies is a manufacturer of a wide range of automotive and heavy vehicle sensors.
- Conducted quality inspections on production processes and finished products at Wabash Technologies.
- Calibrated measurement tools to ensure accuracy and compliance with standards.
- Maintained detailed records of inspections and test results for traceability.
Quality Control Technician
Ward Production Machine
Fort Wayne
11.1999 - 03.2000
- Great experience! Joined when Wabash closed my facility, but was successfully recruited back to Wabash in another group.
- Programmed a DEA CMM using Virtual DMIS software.
- Calibrated gages and maintained a gage database of nearly 500 gages.
- Performed set-up checks for a machine shop and some in-process checks.
- Ward manufactures aluminum castings used in cars and watercraft utilizing its own foundry, pattern and machine shops.
Metrology Technician
Wabash Magnetics
Huntington, Indiana
05.1997 - 11.1999
- Performed dimensional layouts for press and mold qualifications, PPAP’s for Ford and G.M., problem investigations and supplier qualifications.
- Operated and programmed a Helmel manual Coordinate Measuring Machine using LK software.
- Operated and programmed an LK DCC CMM using LK software.
- Calibrated mechanical gages. Responsible for maintaining and correcting a gage recall database for nearly 5,000 mechanical and electrical gages.
- Served as the QS-9000 Element Champion in charge of all measuring and test equipment.
- Was responsible for closing out all Corrective Actions in my element.
Quality Control Inspector
Wabash Magnetics
Huntington, Indiana
11.1995 - 05.1997
- Conducted quality checks on assembly line to ensure compliance with standards.
- Executed final audits and maintained SPC charts for continuous improvement.
Quad Machine Operator
Wabash Magnetics
Huntington, Indiana
05.1994 - 11.1995
- Constructed circuit boards while maintaining and programming the Quad machine.
- Programmed the Quad machine to enhance operational efficiency.
Education
Bachelor of Fine Art - Minor in Biology
University of Saint Francis
Fort Wayne, IN05-1994
Skills
- Internal auditor training
- Problem solving
- Qualification package submission
- PCDMIS programming
- Metromec software programming
- LK CMM programming
- Camio programming
- OGP Smart Scope programming
- Virtual DMIS programming
- Measurement uncertainty calculation
- QS-9000 internal auditing
- LK software CMM programming
- Calibration systems
- Global Electronics (formerly IPC) J-STD-001 certified trainer
- Global Electronics (formerly IPC) A610 certified trainer
Additional Training And Skills
- Internal Auditor Training given by BSI, 05/11
- 8 D Problem Solving, 07/03
- Ethicon Endosurgery – Submitting Part Qualification Packages
- Programming using PCDMIS
- Programming using Metromec Software
- Programming an LK CMM using LKDMIS Software and Camio – a CAD based programming software, 07/02
- Programming of OGP Smart Scope, 05/02
- Programming with Virtual DMIS Software, 02/00
- Calculating Measurement Uncertainty, 10/99
- Internal Auditing for QS-9000, 10/99
- Programming CMM using LK Software, 12/97
- Calibration Systems, 06/97
Timeline
Quality Engineer
Ultra Maritime
03.2024 - Current
Quality Engineer
Incipio Devices
12.2018 - 03.2024
Quality Engineer
L.H. Medical
09.2017 - 12.2018
Quality Engineer
Tecomet (formerly Symmetry Medical)
10.2012 - 09.2017
Quality Engineer
NGInstruments
02.2012 - 10.2012
Quality Engineer
Paragon Medical OMC
01.2011 - 02.2012
Quality Engineer
Symmetry Medical UltreXX
06.2005 - 12.2010
CMM Programmer
Meridian Automotive Systems
11.2004 - 05.2005
Metallurgical Laboratory Technician (Temporary Position)
Karl Schmidt Unisia, Inc.
09.2004 - 11.2004
Quality Engineer
Schnipke Engraving Company
04.2002 - 06.2004
Quality Associate
Wabash Control Products Group
07.2000 - 04.2002
Quality Control Technician
Ward Production Machine
11.1999 - 03.2000
Metrology Technician
Wabash Magnetics
05.1997 - 11.1999
Quality Control Inspector
Wabash Magnetics
11.1995 - 05.1997
Quality Technician
Wabash Technologies (Wabash Optek)
05.1994 - 04.2002
Quad Machine Operator
Wabash Magnetics
05.1994 - 11.1995
Bachelor of Fine Art - Minor in Biology
University of Saint Francis