Quality Assurance/Regulatory Compliance Manager @ Responsible for:
• Quality System planning, implementing, and maintaining as well as managing regulatory compliance of regulations for the site
• Serves as the Site Representative for external regulatory bodies
• Responsible for Safety and Security programs to prevent accidents/occupational incidents and environmental incidents
• Carrying out internal audits and oversee internal audit findings to ensure compliance to regulatory requirements
• Create and maintain required quality system documents and records, including summaries and management reports
• Train employees on quality measures and company policies
• Investigating systems’ challenges and issues
• Working on external and internal measures
• Assure corrective action preventive action (CAPA) activities are managed and addressed appropriately
• Assuring the process and activities of the organization are within international and national regulatory and quality standards
• Defining quality procedures in cooperation with operating staff
• Setting up and maintaining controls and documentation procedures
• Supervising quality assurance staff
• Ensuring that any regulatory changes are implemented From April 2015 to Present (9 months) Senior Supplier Quality Engineer @ Responsible for providing leadership, insight, guidence and problem solving skills to all technical issues encountered by the commodity team in the sourcing, manufacturing, and cost reduction activities for purchased products and services. From September 2011 to Present (4 years 4 months) Supplier Quality Engineer @ Supplier Quality Engineer for Davol Inc, a division of CR Bard, an ISO 13485 ,FDA registered company specializing in hernia and soft tissue repairs with sales of over $2.4 billion. From March 2008 to September 2011 (3 years 7 months) Director of Quality @ Directed all quality activities for Swissline Precision, a ISO 9001:2000, FDA registered company serving the commercial aerospace, medical, electronic and commercial markets.
• Manage activities of 12 quality technicians and a quality manager.
• Leading ISO 13485 certification effort
• Leading AS9100 certification effort
• Leading plant wide SPC project From September 2007 to March 2008 (7 months) Quality Engineer @ Manage supplier quality, supplier evaluations, supplier audits, Supplier Corrective Action Requests, internal and customer Corrective Action Requests, advanced product quality planning activities, statistical process control activities, QRB activities, generation of monthly quality metrics for site and raw material specification generation. Hexcel is the world leader in carbon fiber and advanced composite technology for aerospace industry manufacturing products for commercial and military applications with sales of over $1 billion. From October 2004 to September 2007 (3 years) Quality Manager/Engineer/Supervisor @ Directed daily operation of Quality Assurance department. Hellermann Tyton, a division of Spirent PLC, is an automotive plastics injection-molding firm manufacturing products for the automotive and telecommunication industries with sales over $25 million. From March 2002 to October 2004 (2 years 8 months)
MS, Quality Systems Management @ The National Graduate School From 2011 to 2012 BS @ Bridgewater State College From 1984 to 1987 Jim Thomson is skilled in: SPC, Six Sigma, Supplier Development, ISO 13485, V&V, Process Capability, Auditing, Quality System, FMEA, ISO, Root Cause Analysis, CAPA, Design Control, Lean Manufacturing, FDA