Kent Yonker Email & Phone Number

Canton, GA

• Reported to the Production Quality Manager. Supported the development of a robust Production Quality Audit Program for the manufacturing site activities of Class 2 medical products.
• Defined the processes needed to develop a very thorough review (audit) of the manufacturing, quality, safety and product protection elements in place for the production of sub-assemblies and finished products.
• Conducted product audits for each manufacturing cell and production line to support all products manufactured.
• Developed Production Quality Audit reports at the completion of each one, presenting the Gap findings, observations and suggested improvements to staff Quality and Engineering personnel.

Alpharetta, GA

• Reported to the Head of Customer Quality and CI, Q & R - North America (NA) Market within a staff of five. Supporting Field Service Center Q&R activities of – CAPA facilitation, site documentation, complaint review.
• Facilitated NA Market CAPA activities, timely addressing 100+ diverse audit response and improvement CAPAs aligning to corporate defined initiatives & KPI metrics.
• Supported site compliance to corporate policies, ISO 13485 Standards, cGMP and international regulatory requirements, through annual corporate and multiple site internal audits.
• Completed site and NA market projects in Technical Service Escalations, FDA observation CAPAs, NA and LATAM Market Ship Holds, with quality tools and regulatory requirement support.

Tucker, GA

• Reported to the Business Unit Quality Director of this Class 2 medical device manufacturer, managing a staff of eight.
• Participated as a core member of facility management to achieve annual SMART goals in quality (DPM, FPY, CPM, 0 Recalls, 0 Major NC), cost (3% savings) and service (97%+ on-time delivery).
• Supported R&D projects with core quality tools and requirements for successful introductions of 3 new product families (100+ codes) to the facility within two years.
• Applied Quality-at-the-Source (QATS) process within instrument assembly creating operator quality ownership, raising initial product acceptance (throughput yield) from 72% to 98%.

Sarasota, FL

• Reported to the President of privately held thermos-plastic packaging materials manufacturer managing a staff of eight.
• Implemented package process validations (IQ, OQ, PQ, PPQ) with a major medical device customer to assure product integrity of package design change and support for Six Sigma project driving out over $200,000 in costs.
• Defined Total Quality manufacturing approach to support the diverse needs of the $4.2 million medical device customer base, achieving superior audit rating from a Fortune 50 medical customer.

St. Petersburg, FL

• Reported to the Plant Manager of a facility producing corrective lenses (Class 1 medical device) managing a staff of 49.
• Spearheaded successful implementation process for plant ISO 9001 QMS, achieving registration in 9 months.
• Developed Quality-at-the-Source (QATS) process creating quality ownership within production, raising product acceptance 1.5% at a savings of $500,000/yr. and cutting customer complaints by 66%.
• Applied preventive action projects, one reduced quality factor from 1461 PPM to under 300 PPM in two years.