Julie Harrell

I have a total of 30 years of experience in quality control. Twenty-five of those years as a quality engineer. I have worked in the medical device, defense, and automotive industries.

Ultra Maritime, Columbia City, Indiana

3/ 2024 - Present

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

• Served as solder training coordinator
• Certified trainer of IPC-J-STD-001
• 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

12/ 2018- 3/ 2024

Incipio Devices manufactures orthopedic surgical instruments and implants for several major orthopedic companies

Quality Engineer 

• New product introduction 
• Create inspection criteria 
• Review in-coming material
• Review shipping paperwork 
• Train operators on inspection techniques 

09/ 2017-12/2018

L.H. Medical manufactures orthopedic surgical instruments and implants for several major orthopedic companies

Quality Engineer 

• Responsible for creating inspection instructions for new and legacy products 
• Created control plans. 
• Created PFMEAs
• Preformed product inspection.

Tecomet manufactures orthopedic surgical instruments for all of the major orthopedic companies

Quality Engineer 

• 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.

NGInstruments manufactures orthopedic surgical cutting instruments for all of the major orthopedic companies.

• Responsible for answering customer CAPA requests and complaints.
• Responsible for quality activities associated with new product launch.

• Responsible for logging and answering customer CAPAs and complaints.
• Handle all returned product, manage containment activities and direct disposition and rework of returned product.
• Perform all internal audits for the facility. Received a week-long training class from BSI. Scored a 91% on the final test.
• Issue CAPAs to suppliers. Follow up to ensure a timely response.
• Responsible for quality activities associated with new product launch.

Symmetry Medical manufactures orthopedic surgical implants and instruments for all of the major orthopedic companies

Quality Engineer 

• 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.

Purdue University - Fort Wayne – Bachelor of Fine Art, 1994

Minor in Biology, Dean’s List Senior Year

Select Coursework

Drawing, Graphic Design, Photography, Computer Graphics, Sculpture, 2-D Design, Human Anatomy and Physiology, Zoology, Biology I, Chemistry I & II, Trigonometry I & II.

* Illustrated a laboratory manual for Human Anatomy and Physiology.