Elizabeth Culler Email & Phone Number

Cumming, GA, US

United States

Norcross, GA

• Transfer project core team Quality support aiding in a medical device facility transfer from Portland, OR to Norcross, GA.
• Managed calibration schedule for all transferred equipment.
• Supported the layout, installation and setup of the Quality Labs.
• Created relocation equipment protocols and reports for startup facility.
• Researched and made recommendations for new finished goods test equipment. Managed purchase, installation and executed Gage R&R to validate new… Show more
• Researched and made recommendations for new finished goods test equipment. Managed purchase, installation and executed Gage R&R to validate new equipment.

Ball Ground, GA

• Project lead for the implementation of a liquid cooling system to decrease process time and decrease gas usage. Created timeline, PFMEA, Program Validation (CSV) and IQ/OQ/PQ.
• Completed Deviation Report including process capability (Cpk) for new hydrostatic test equipment to account for pressure losses.
• Audited existing CAPA process and updated procedures to comply with ISO and TS 16949
• Provided support for new OEM product line. Created timeline, PFMEA, worked with team to… Show more
• Provided support for new OEM product line. Created timeline, PFMEA, worked with team to determine the equipment needed, obtained quotes and prepared the funding request.
• Used Cpk analysis to validate that production process and engineering design changes implemented resolved the nonconformance or truly improved the process capability.

• Project lead for new biopsy gun product line. The project included; working with the buyer for supplier selection, approval, and F/A requirements, worked with quality support to develop the protocol for the equipment.
• Supported Dominican Republic Transfer Project. Updated and created facility layout in Visio. Worked with facility to develop validation protocols. Executed validations for HiPot Testers… Show more
• Supported Dominican Republic Transfer Project. Updated and created facility layout in Visio. Worked with facility to develop validation protocols. Executed validations for HiPot Testers and Glue Machine in the DR.
• Worked with the Quality Department to validate Hipot Testers in order to rectify FDA audit finding.
• Provided Engineering support for OEM product line. Support included nonconformance investigations, validating equipment; HiPot testers and OGP SmartScope, and process improvements.
• Worked on DOE for OEM product line to determine correlations with the test method. Worked with Quality on test method validations.

Performed tasks related to accounting including reconciling, monthly sales tax reports, and collection of tax information to send to the accountantHandled the company's transactions and monitored cash flow Managed Accounts Receivable and Accounts PayableWrote Invoices using Auto Shop for WindowsManaged expansion to new larger location (2,500 sq ft to.

Master Of Science, Quality Assurance

Bachelor Of Science, Industrial Engineering Technology