Cook Medical · 9 hours ago
Quality Engineering Manager, CAPA
Bloomington, IN
Full-time
Onsite
Senior Level
5+ years expCook Medical is a company focused on ensuring compliance and adequacy in quality management systems. The Quality Engineering Manager will lead a cross-functional team, managing day-to-day quality operations and overseeing processes such as CAPA and Nonconformance Investigation.
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 both direct and indirect cross-functional leadership to management and operational personnel
Responsibility 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
Maintain the process in the Quality Management System to ensure meeting FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements
Participate in hiring, interviewing and onboarding process of new hires
Responsible for performance management and annual reviews of direct reports
Attend, present and provide data for meetings to include project updates and reviews
Authorization of weekly time sheets, concur, PTO request, department specific documents
Manage the CAPA process and associated personnel both inside and outside fo the function in order to ensure swift, effective, compliant corrective and preventive actions
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
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
Minimum of 5 years experience in an FDA-regulated industry, preferably in a medical manufacturing environment
Minimum 5 years experience working with quality management system
Bachelor's degree in Engineering or Life Science
Proficient in Microsoft Word/Excel/Project/Outlook, JBase, Livelink, Business Objects
Experience in project management required, 5 years preferred
Experience in root cause analysis and corrective action required, 5 years preferred
Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth
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
Preferred
Previous leadership experience, 5 years preferred
Experience in project management required, 5 years preferred
Experience in root cause analysis and corrective action required, 5 years 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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