Summary Statement
Seasoned Quality Systems Manager with 15+ years of management experience and knowledge of quality and operational management systems, industry and regulatory standards and business performance metric implementation and reporting.
Professional, flexible, creative, and service-oriented. Offering a unique combination of creativity and analytical skill with the ability to assess both vantage points to create cost-effective solutions customers and plant operations.
Work Experience
Jabil
Manufacturer of Circuit Boards and High Level Medical Device Assemblies
Auburn Hills, MI
January 2011 to Present
Quality Systems Manager
• Develop and facilitate training for all plant personnel based upon 21CFR820 (QSR and GMP), ISO 9001, ISO 14001, ISO 13485 and associated regulatory standards and requirements.
• Verify and sign off on completion of all required training for all Standard Operating Procedures and Work Instructions.
• Lead and mentor operations on compliance investigation findings; issue reports and corrective actions.
• Coordination of Customer Quality Systems Audits and ensuring all customers product/system requirements are obtained, understood and communicated.
• Ensures effective interactions at department level with quality team to incorporate departmental activities into overall site/organizational strategies and quality systems.
• Responsible for process effectiveness and the integrity of the quality system processes (i.e., quality management system operating procedures, document and record control requirements, site training, and corrective and preventive action process).
• Responsible and accountable for plant level compliance with 21CFR820 (QSR and GMP), ISO 9001, ISO 14001, ISO 13485 and other applicable regulatory standards and requirements.
• Accountable for validation processes implementation and review and approval of process validation activities.
• Management Representative for the ISO 9001, ISO 13485 and ISO 14001 Management System certifications.
Eagle Group USA, Inc.
Consulting and Training Firm
Rochester Hills, MI
September 1995 to December 2010
Senior Consultant and Partner
• Lead Designer for Training Course Development Process
Developed 20+ courses for various customer specific as well as general industry applications.
• Senior Instructor in areas such as: Corrective Action & Problem Solving, Internal Quality Auditing, Technical Writing, Risk Analysis and TCOQ (Total Cost of Quality) Metrics.
• Development and Implementation of Quality Management Systems for the following Standards:
o ISO 9001 – General Industry,
o ISO 13485 – Medical Devices,
o ISO/TS 16949 - Automotive, and
o TL9000 - Telecommunications
• Development and Implementation of Environmental, Health, Safety and Security Management Systems in support of :
o ISO 14001 – Environmental for General Industry,
o Responsible Care RC14001 – Chemical Industry, and
o OHSAS 18001 – Occupational Health and Safety
• Developm...
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