Cook Medical · 13 hours ago
Manager, Quality Engineering
Bloomington, IN
Full-time
Onsite
Senior Level
5+ years expCook Medical is a company focused on quality management in the medical field, and they are seeking a Quality Engineering Manager to oversee day-to-day quality operations. The role involves managing quality processes, ensuring compliance with regulatory standards, and providing leadership to the functional team.
HardwareManufacturingMedical Device
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
Responsible and authority for ensuring that processes needed for the quality management system are documented; reporting to top management on the effectiveness of the process(es) and the need for improvement; promoting the awareness of applicable regulatory and quality management system requirements throughout the organization
Prepare, communicate and monitor quality plans and metrics to support operations
Maintain the process in the Quality Management System to ensure meeting FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements
Attend, present and provide data for meetings to include project updates and reviews
Participate in hiring, interviewing and on boarding process of new hires
Responsible for performance management and annual reviews of direct reports
Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth
Excellent problem solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision
Must work and interact effectively and professionally with and for others throughout various levels of the global organization
Must strictly adhere to safety requirements
Maintain regular and punctual attendance
Must maintain company quality and quantity standards
Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with minimal supervision
Ability to remain calm and receptive in fast paced situations
Qualification
Required
Bachelor's degree in Engineering or Life Science or experience of such kind and amount as to provide a comparable background
Minimum of 5 years experience in a regulated industry, preferably in a medical manufacturing environment
Minimum 3 years experience working with quality management system
Previous leadership experience, 5 years preferred
Proficient in Microsoft Word/Excel/Project/Outlook, JBase, Livelink, Business Objects
Works under general office environment conditions
Utilizes close visual acuity for working with computers and equipment
Frequently required to stand, walk, and communicate
Occasionally lifting with minimal exertion during shift
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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