Quality Assurance Manager

The Quality Assurance Manager at Cook Medical is responsible for working with process owners, subsystem leaders and other functions in helping to maintain a compliant, effective and efficient quality system for the AMER Support Center and AMER Distriburtion Center.

• Serve as site Management Representative - host audits, identify appropriate quality data, provide independent review of quality system performance at all levels and reporting any issues
• Facilitate third party audits and inspections; coordinate responses to the audits/inspections and ensure that findings are addressed appropriately
• Ensure that the Quality Management System and the processes needed to ensure product quality are implemented, understood, and maintained
• Ensure that issues requiring improvement are identified and fed to CAPA appropriately
• Communicate directly with designee(s) at Cook manufacturing sites regarding changes made to the quality system affecting regulatory submissions
• Regularly monitor performance of the Quality Management System and communicate deficiencies to responsible personnel
• Communicate within the supply chain for matters relating to the quality system
• Maintain knowledge of federal, state, and local regulatory requirements applicable to work performed in the AMER Support Center and AMER Distribution Center 
• Refine and implement regulatory practices as needed to meet regulatory compliance
• Serve as process owner for Management Review
• Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth
• Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements

• Bachelor's degree Engineering or Life Science or experience of such kind and amount as to provide a comparable background

• Minimum 3 years experience in quality systems experience; management experience preferred
• Knowledge of quality tools and principles
• Knowledge of medical device regulations, pertinent standards and guidances
• Proven written and verbal communication and problem solving skills
• Basic knowledge of statistics
• Possess a working knowledge of ISO 13485 and other applicable standards

• Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position

Physical Requirements:

• This position is a remote position, but may be required to make periodic visits to the facility, based on manager and leadership discretion
• Must reside within a 1-hour radius via car, of the Cook Medical LLC facility in Bloomington, Indiana

• Works under general office environment conditions

• Sitting for extended periods, utilizes close visual acuity for working with computers, equipment, etc.
• Some travel may be involved