Experienced, results-producing professional with experience steering and directing all aspects of operation, administration, quality, and validation. Success managing multiple projects with competing priorities involving program developments, safety, and quality control. Facility Quality Assurance Manager with ISO 9001 and TS 16949 involvement. Quality Assurance Manager with cGMP experience. Experience in:
Customer Relations Management
Cost Control & Reduction
TQM & PRIDE Teams
Masters of Science Management / Liberty University /Sigma Beta Delta/ 2009 Bachelor of Arts Organizational Management / Midway College / Graduate with Distinction / 2006 Associate of Applied Science--Electrical Engineering Technology / Lexington Community College / Phi Theta Kappa Associate of Applied Science Information Technology. Security / Maysville Community College/ 2011 Additional courses--Six Sigma, Lean Manufacturing, Project Management, ASQ Certifications – CBA, CQE, CPGP; QAKE Training QUALITY ASSURANCE MANAGER 2009-NOW
BEST SANITIZERS/WALTON, KY
Train and provide guidance to cGMP Pharmaceutical/Medical Device FDA Compliance
Manage the Quality Unit
Manage, plan and conduct Self Improvement Program
Maintain and review CAPAs, Deviations, Out of Specs and NCRs
Administer Design History File
Conduct Government Registrations
Perform trending analysis on failures, analyzing and interpreting data.
Annual Product Reviews
Administer Management Reviews
Document Reviews, Change order Requests
Establishes and maintains quality management system to 21 CFR210, 21 CFR211, 21 CFR820, ISO9001, ISO13485
Customer Complaints and RMAs
Ensure validation protocols are conducted for new and changes to product processes and equipment PROGRAMMING PRODUCTION SUPERVISOR - FACILITY QUALITY ASSURANCE MANAGER 1993- 2008 AVNET / LEXINGTON, KY
Responsible for management of multiple functions within production/warehouse center.
Prepared first articles and PPAPs.
Assisted programming centers in developing support for engineering, logistics and production.
Coordinated shipping/receiving/ scheduling, planning and JIT orders with production according to customer requirements.
Developed qualification procedures, monitored and reported product test data
Analyzed technical data and reports to determine direction and initiate proactive measures to attain goals.
Ensured Control Plan requirements were met.
Established calibration requirements and maintenance tasks for in house equipment.
Determined and recorded SPC requirements and data; performed trend analysis for common cause, scrap, and rework.
Researched/wrote/edited operating policies for equipment and established acceptable standards for local facility.
Liaison between customers and production to ensure quality outcomes. ACCOMPLISHMENTS:
Implemented new operating rules for automated equipment that saved $70,000/annually.
Created bar coding system to track and inventory replacement parts.
Led Lean projects that examined different processes; developed new inspection and labeling systems.
Increased group efficiency from 80.1% to 88.7%.
Used Lean manufacturing principles, to reduced changeover process from 45 to 25 minutes while increasing quality.
Downsized facility from 2 to 1-shift operation; reduced quality costs 7% while maintaining high morale standards.
Maintained 12 months of 100% on time delivery and zero customer returns.
Key member of Lean Manufacturing initiative in development of POP program to establish quality goals: created training criteria/test and personally trained each operator to assume individual responsibility for quality.
Achieved first articles return processing of 4 hours (24 hours policy from date of receipt) allowing greater opportunity to increase customer base.
US Army Veteran