Director, Quality Assurance - Cook Inc.

The Director, Quality Assurance at Cook Incorporated assists the VP, QA in leading the Company in all matters relevant to the QMS as established by customer, regulatory and external standards requirements. This position is responsible for ensuring that the QMS are effectively understood, implemented and maintained at all levels and monitored for effectiveness in meeting quality objectives, and improved when objectives are are not met.

• Oversee the adequacy and maintenance of the QMS in meeting the requirements of the Cook entities and liaise with external accredited agencies
• Ensure that reports are made to Management with Executive Responsibility (MER) on its performance, status and areas that require improvement
• Ensure that awareness of regulatory and customer requirements is communicated with both staff and Management
• Assist in establishment, maintenance and adequacy of the QMS
• Foster and maintain a workplace culture respectful and supportive of individual differences

• Serve as Management Representative
• Serve as a Person Responsible for Regulatory Compliance in accordance with the EU MDR and ensue that the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released.
• Must work and interact effectively and professionally with and for others throughout various levels of the global organization
• Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth
• Adhere to the Quality Management System to ensure meeting FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements, driving quality throughout the organization

• Bachelor's degree in related field or experience of such kind and amount as to provide a comparable background
• Master's degree preferred
• 10+ years of related industry experience
• 5+ years in a leadership role

• Experience in managing audits from regulatory authorities
• Experience leading large quality organizations preferred
• Experience in regulatory affairs and regulatory compliance preferred
• Experience in streamlining a QMS preferred
• Experience in medical device manufacturing preferred
• Proficiency in risk management, validation, supplier quality and continuous improvement methods preferred

Physical Requirements:

• This position requires on-site support and may on a periodic basis include requirements to travel to other locations domestically and internationally
• General office environment
• Sitting for extended periods

• Requires close visual acuity when working with computers, etc.