Mitchell Hicks Email & Phone Number

Morrisville, North Carolina, United States

Raleigh-Durham, North Carolina Area

• Facilitated cross-functional teams to document necessary information for executive management to assess if field actions/corrections and removals associated with Teleflex products are warranted per 21CFR part 806 and comparable standards worldwide.• Led cross functional teams to investigate and resolve problems of product design, specifications, materials, tooling and manufacturing affecting product quality across various Business Units• Executed global product ship holds to contain and disposition nonconforming material within company control• Trained Associate Quality Engineers/Quality Engineers on ship hold originator roles and responsibilities• Facilitated project to establish change management process for Surgical Instruments• Liaised with Business Units on nonconformances, risk evaluations, and additional quality activities related to Post Market Quality Assurance• Led and served as subject matter expert for CAPA teams to eliminate/mitigate systemic quality issues• Prepared slides for quarterly Management Review and monthly Product Quality Review presentations for executive management to assess quality system and product level risks and escalate where appropriate• Compiled and presented data for monthly Quality System Review Board meetings• Led Supplier Corrective Action Request (SCAR) investigations to eliminate supplier-related quality issues• Completed Risk Evaluations for product-related issues to determine proper escalation• Provide responses for global Regulatory Queries related to product quality evaluations/investigations• Served as Study Group Leader for the ASQ Certified Quality Engineer examination• Provided support for areas of subject matter expertise during internal and external audits (e.g., notified body, FDA)

Raleigh-Durham, North Carolina Area

Asheboro, North Carolina

 Performed root cause analysis of major issues of product lines to assist operators and documented best practices for troubleshooting Created, organized and implemented optimal layout for WIP inventory area. Researched and implemented system of tracing non-conforming products from production through rework. Recorded and video-edited SOPs using Pinnacle Studio Ultimate 18 software.

Goldsboro, North Carolina

 Provided management with status of the equipment milestones deliverables required for the development/certification of AAR’s A400M Floor Base Cargo handling System/ Aerial Delivery System for SOC 1.0 and SOC 1.5.  Reported on $16M project status to ensure milestone completions. Learned organizational skills and how to effectively communicate data and results electronically. Created detailed layout drawing of Test Lab in modeling software.

Winston-Salem, North Carolina

 Developed plan and metrics to measure value of the current projects. Helped run test to prove validity and cost efficiency of current projects.  Learned effective work ethic in a professional team setting. Presented findings and recommendations before immediate team, Vice President of the group and other leaders.