Cook Medical · 15 hours ago
Director, Quality Assurance
Bloomington, IN
Full-time
Onsite
Director/Executive
10+ years expCook Medical is seeking a Director of Quality Assurance to assist the VP, QA in leading the company's Quality Management System (QMS) efforts. This role is responsible for ensuring the QMS meets regulatory and customer standards while fostering a supportive workplace culture and driving continuous improvement.
HardwareManufacturingMedical Device
Responsibilities
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
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
Qualification
Required
Bachelor's degree in related field or experience of such kind and amount as to provide a comparable background
10+ years of related industry experience
5+ years in a leadership role
Preferred
Master's degree preferred
Company
Cook Medical
Cook Medical is a medical device company that specializes in designing, manufacturing, and delivering invasive medical devices. It is a sub-organization of Cook Group.
10001+ employees
H1B Sponsorship
Cook Medical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2023 (3)
2022 (2)
Funding
Current Stage
Late StageLeadership Team
G
Gayle Cook
Co-founder
Kelly Fischer
Senior Vice President and Chief Financial Officer
Recent News
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