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Quality Engineering CAPA Manager

Cook Medical

Cook Medical

Quality Assurance
Bloomington, IN, USA
Posted on Friday, May 24, 2024

Quality Engineering CAPA Manager

Requisition ID 2024-14617
Posting Date 1 week ago(5/23/2024 10:29 AM)
Job Location(s)
Bloomington IN United States
Less than 10%
Position Type
Full Time
Cook Inc - Bloomington


The Quality Engineering Manager 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.


  • Manage the CAPA process and associated personnel both inside and outside of the function in order to ensure swift, effective, compliant corrective and preventive actions.
  • Manage Non-conformance Investigation processes (NCI & ICNC)
  • Leads team of NCI and CAPA owners to drive investigations, documentation and appropriate actions. Develops and monitors metrics to ensure compliance and continuous improvement.
  • Support Internal and external Audits and Audit response activities.
  • Must have the ability to influence other functions and indirectly drive project management activities as it relates to CAPA, NCI, and ICNC.
  • Drives continuous improvement in Cook Inc. Quality Management System.
  • 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
  • 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
  • Maintain the process in the Quality Management System to ensure meeting FDA 21 CFR 820, ISO 13485, and other applicable regulatory
  • Must work and interact effectively and professionally with and for others throughout various levels of the global
  • Must strictly adhere to safety
  • Maintain regular and punctual
  • Must maintain company quality and quantity
  • 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 respectful in fast paced


  • Minimum of 10 years experience in an FDA-regulated industry, preferably in a medical manufacturing
  • Minimum 5 years experience working with quality management
  • Previous leadership experience, 5 years
  • Bachelor's degree in Engineering
  • Proficient in Microsoft Word/Excel/Project/Outlook, JBase, Trackwise, Livelink, Business
  • Experience in project management required, 5 years preferred
  • Experience in root cause analysis and corrective action required, 5 years preferred

Physical Requirements:

• 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


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