Elizabeth Culler Email & Phone Number

Cumming, Ga, Us

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 • 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 equipment. • Created the design qualification and IQOQPQ protocol to validate the new Class 7 Controlled Environment Cleanroom. • Created and presented Manufacturing 101 training to grow awareness to new employees. • Provided training and Quality auditing at production startup. • Created NCMRs, RWs, PDs, and CAPAs as required.• Performed work instruction auditing and updates per quarterly schedule and updates required to reflect changes needed through the transfer. Show less

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 • 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 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. • Completed Validation, Gage R&R, procedures, and programming for new data plate engraver.• Developed processes to protect products from damage in transit. This effort was to reduce customer complaints and improve quality of delivered product. Performed engineering testing to ensure solution was viable. • Worked with maintenance and safety on crane certification, repairs load rating and load testing. • Analyzed and evaluated current validation procedures. Offered areas of potential improvements.• Worked with product engineers and production on small part design improvements to aid in product manufacturing.• Worked on two projects that identified new equipment to allow part standardization and cost savings on incoming raw material; radial arm drill and data plate machine. • Completed Validation Plan for automated insulation application.• Completed root cause analysis investigation for soldering issues and developed action items to narrow potential causes. Next steps will be to identify root causes and implement an improvement plan. • Have led multiple CAPA Teams to put corrective and preventative actions in place for nonconformities.• Daily functions involve working with my value stream to manage metrics driven by SQDC boards. Show less

• 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 validation and completed required documentation and timelines for Design History File. • 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 • 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 validation and completed required documentation and timelines for Design History File. • 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. • Created Process Maps for all RMI Products and identified the critical processes• Implement startup inspection process and procedures in order to improve final quality and eliminate scrap. • Mentored Industrial Engineering Interns performing their Senior Project• Provided Engineering support for product extension project for OEM customer. Support on this project was limited to documentation updates and product transfer documentation for the design history file. • Completed Simulated Use Testing to support investigation for product compliance. Show less

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 15,000sq ft facility)Performed many analyses to reduce costsRecently designed a Six Sigma process to help manage new… Show more 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 15,000sq ft facility)Performed many analyses to reduce costsRecently designed a Six Sigma process to help manage new overhead costs and profits Worked with banks to acquire a $750,000 loan for the new facility (Loan closed November 2009)Currently performing end of year audits on all accounts Show less

Master Of Science, Quality Assurance

Bachelor Of Science, Industrial Engineering Technology