The Quality Systems Manager plans, organizes and controls the quality management system activities related to CAPA, internal audits, supplier quality, post market surveillance, design quality, management review, training and communication with the global Clinical Innovations facilities. Works to help establish and maintain the Quality Management System (QMS) to ensure compliance with all applicable federal and international standards. Organize and maintain documentation regarding regulatory compliance, FDA requirements, and provide leadership for problem solving, facilitate improvements in quality management.
• 4 year Technical Degree
• 7 plus years relevant experience
• Extensive experience quality management systems.
• Must be able to effectively interact with applicable regulatory agencies at the local and/or bureau level.
• Strong project management skills
• Strong attention to detail
• Preferred Licenses/Certificate: ASQ (CQM/OE, CQE, CQA-Biomed, etc.); RAPS (RACUS, RACEU, and RACCAN); 6 Sigma (Black/Green Belt); AAMI (CBET, CRES, etc.)
Training Requirements per training matrix
ESSENTIAL DUTIES AND RESPONSIBILITIES:
The following duties and responsibilities are intended to be representative of the work performed by the incumbent(s) in this position and are not all-inclusive. The omission of a specific duty or responsibility will not preclude it from the position.
• Responsible for managing the quality system at the SLC Clinical Innovations site as well as the international Clinical Innovations sites with regards to CAPA, post market surveillance, supplier quality, design quality, and training
• Assure effective systems and controls are established and maintained to demonstrate an effective quality management system
• Establish robust, aggressive systems to assure corrective and preventive measures are systematically implemented, monitored, and controlled
• Provide expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies to assure compliance.
• Develop and implement processes and procedures to assure a compliance-oriented environment meeting internal and external requirements and standards.
KNOWLEDGE AND SKILLS:
• Direct experience in establishing and maintaining corporate procedures as they relate to the FDA Quality System regulations, ISO 9001, ISO 13485, the Medial Device Directive 93/42 EEC, MHLW Ordinances, MDSAP, MDR, IVDR
• Experience in establishing and maintaining an effective post market surveillance system
• Direct experience conducting and managing internal and supplier audits
• Demonstrated experience in leading management review
• Demonstrated experience and results in building effective quality management systems
• Preferred manufacturing experience
ORGANIZATIONAL RELATIONSHIP: Reports to: Sr. Director of Quality. Supervises: Quality Systems Engineer, Supplier Quality Engineer, Complaint Analyst