Overview The Quality Assurance Manager at Cook Capital Equipment serves on a cross functional team, ensuring the adequacy, suitability and compliance of specified Quality Management System processes. Manages day-to-day quality operations and provides leadership and direction to the functional team. Responsibilities • Approve quality documents, analyze improvement of the QMS and other department processes, including reviewing, updating, creating, and implementing SOP’s to support improved processes and compliance • Provide quality expertise and leadership to management and operational personnel • Actively assure operational observance to compliance obligations to include, regulatory, contractual, and SOP driven requirements • Actively look for ways to improve quality processes and procedures • Attend, present and provide data for meetings to include project updates and reviews • Participate in hiring, interviewing and onboarding process of new hires • Responsible for performance management and annual reviews of direct reports • Authorization of weekly time sheets • Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth • Develop plans to evaluate improvement projects Qualifications • Bachelor's degree in Engineering or Life Science or equivalent experience • Minimum 3 years experience in a regulated industry, preferably in a medical manufacturing environment • Minimum 3 years experience working with quality management system • Previous leadership experience • Proficient in Microsoft Word/Excel/Project/Outlook, JBase, Livelink, Business Objects “Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time. Physical Requirements: • Works under general office environment conditions • Utilizes close visual acuity for working with computers and equipment • Frequently required to stand, walk, and hear • Occasionally required to lift up to 20 pounds Requisition ID2025-16075 Posting Date3 hours ago(2/12/2025 2:05 PM) Job Location(s)Spencer IN United States Job LocationsUS-IN-Spencer Position TypeFull Time CompanyCook Capital Equipment CategoryQuality