Overview
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.
Responsibilities
Oversee the adequacy and maintenance of the QMS in meeting the requirements of the Cook entities and liaise with external accreditedagencies
Ensure that reports are made to Management with Executive Responsibility (MER) on its performance, status and areas that requireimprovement
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
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
Qualifications
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
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.
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Responsibilities
Oversee the adequacy and maintenance of the QMS in meeting the requirements of the Cook entities and liaise with external accreditedagencies
Ensure that reports are made to Management with Executive Responsibility (MER) on its performance, status and areas that requireimprovement
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
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
Qualifications
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
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.
#J-18808-Ljbffr