Certified Manager of Quality/Operational Excellence - CMQ/OE (ASQ). Experience with quality system implementation and continual improvement (ISO 9001, IATF 16949), compliance in regulated industries (automotive, med device), continuous improvement process, and employee training programs to add value and improve efficiency.A history of quality successes achieved through process understanding and continual improvement. Reduced scrap rates, effective supplier controls, and improved operational efficiencies are just some benefits achieved through the application of quality principles. My philosophy is that quality efforts should pay for themselves when implemented properly. Experience with Quality systems/production controls/regulatory compliance in the medical device manufacturing field includes progressive duties leading to a senior management position as Director- Quality Assurance. Design and implementation of a quality management system to meet ISO 9001:2008 and 13485:2003 requirements for the design and manufacture of automated lab equipment and associated Array Tape consumable.Manufacturing background with Process Engineer/Production Supervisor/ISO Management & Quality Assurance experience.Specialties: Implementation and improvement of FDA QSR / ISO13485 / ISO9001/ CE / MDD 93/42/EEC compliant quality/regulatory systems (FDA Class 3, ISO Class 2b medical device) including PMA/Technical File submissions, CAPA, supplier compliance/relations, and principal company contact for FDA/ISO site inspections.Development and implementation of OSHA-compliant safety programs for manufacturing operations.Certified HACCP Auditor (CHA) (ASQ)- Food Safety.
Listed skills include Quality System, Capa, V&V, Medical Devices, and 40 others.
