Cook Medical Quality Assurance Manager in Spencer, Indiana


The Quality Assurance Manager at Cook Spencer is responsible managing quality program of the product to ensure systems meet customers specifications and requirements and manages day-to-day operations and provides leadership and direction to the functional team.


• 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


• 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

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 ID2018-5424

Job Location(s)Spencer IN United States


Shift TypeFirst

Position TypeFull Time

CompanyCook Spencer