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Michael Stevens
Quality Manager - Advanced Technical Center @Hoya Vision Care
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WORK HISTORY
Quality Manager - Advanced Technical Center @Hoya Vision Care
Minneapolis, MN, US
Led ATC to ISO certification in 5 months, due to reorganization within Hoya. a. As Project Manager, customized the Hoya production QMS to ATC, an R&D organization. b. Chaired Management Reviews and served as the Management Rep for ISO audits. c. Revamped the document control and CAPA processes to suit the needs of ATC.2. Continue to lead the QMS for ATC as the Management Rep, CAPA and Document Control Administrators, Technical Writer and Audit Manager.3. Manage the quality testing and metrology groups, supporting multiple new product launches.4. Led the ISO 13485 QMS upgrade project in the first year. Shifted focus in the second year to increasing staff (from 4 to 10) to support the project and testing needs.
EDUCATION
University of Minnesota Morris
Business
UMN Carlson School of Management
BS, Business
SKILLS
ABOUT MICHAEL STEVENS
Quality Assurance Professional• Develops QMS (Quality Management Systems) that add business value by incorporating ISO 9001, ISO 13485 and TS 16949 elements.• Drives continuous improvement in products (PPAP tools such as flowcharting, PFMEAs, Control Plans, and root cause analysis CAPA systems) and processes (six sigma / LEAN and quality audits).• Experienced line manager in R&D, service and manufacturing industries, with direct and indirect reports in remote locations, and in resolving customer issues. • Facilitates improved supplier performance through quality audits and surveys, and clear communication of expectations and requirements.Specialties: Management • QMS (ISO9001, ISO 13485, TS16949) • CAPA (Corrective and Preventive Action) • Inspection • Project • DocumentationProcess Improvement / Quality Engineering • Process Flowcharting • Procedure and Forms Development • Six Sigma Tools (Green Belt) • PPAP Tools (Flowcharts, FMEAs, Control Plans)Audits • ISO Based Internal Audits • Supplier Audits – Multiple Industry Sectors
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