Jack Hedden: Quality Engineer in Arden, NC

• Draft validation protocols and validation summary reports • Perform engineering tests and analyze data using MiniTab software tools • Lean Green Belt certified. Lead Kaizen and SGA within the facility to achieve cost savings through refined processes and significant scrap reduction activities. • Develop and generate packaging specification, visual defect guides, and control plans for validated products and processes. • Process ISO13485/FDA Part 820 related QMS documents.

• Create and revise controlled documents per approved and established Quality Standards (EN ISO 13485:2003 & FDA 21CFR Part 820) • Manage internal quality system audits. Customer audits on-site and off-site. • Daily use of Adobe Acrobat Pro, Excel, Access, Word, Power Point, Visio for deployment and maintenance of various database and forms. • Assist with customer requests for certifications of compliance, sterility, conformance • Fulfill customer requests for regulatory/quality inquiries including product surveys as well as company on-site evaluations • Manage off-site long term storage of controlled documentation per established standards • Develop and maintain reporting structures within SAP ERP System.

• Duties include daily goods receiving of domestic freight, creation of overseas container packing slips, and product labels as needed. Other duties consist of maintaining records of overseas container receipts as well as maintaining monthly and yearly statistics • Reduced inbound freight relabeling by 40% • Helped develop and maintain a Key Factor report for the Raw Materials Department to facilitate improvements in various aspects of the business • Developed various in-depth skills with the SAP user interface. Including but not limited to: PO creation, goods receiving, inventory management, and various reporting functions

• Supervise night shift Quality Inspectors as well as material handlers and Mold Techs. Duties included ensuring shift staffing requirements, maintaining proper head count, initiated disciplinary/corrective action where needed, as well as initiate performance reviews for all permanent and temporary employees on the shift • Reduced scrap rate on the shift from 12% to 3% in the first 3 months using lean principles • Ensured quality of parts being produced by implementing regular spot checks at molding presses • Completed Paulson Interactive Training in regards to molding processes

• Create/revise all operator related documentation using Word and input charts into Word and Excel. Other duties included adding illustrations which were either drawn in Word or using Corel Draw Graphics Suite into the Work Instructions • Create/revise Bill of Material and Routings for the Engineering Department using Excel and Access for control and distribution purposes. Organized a DCO (Document Change Order) process for controlled documentation to for approval (per ISO 9001 standards) • Established time standards using time and motion study methods for all jobs in the facility. Reorganized line flow and developed flow charts for various product lines to streamline flow of production and reduce labor cost • Controlled documents per ISO and Military standards both electronically and physically to allow controlled electronic access by 2 facilities.