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, market related ship hold and internal audit support – for Class 2 medical products.• 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.