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Quality Engineering CAPA Manager
3 months ago
Overview
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.
Responsibilities
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
Qualifications
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 preferredPhysical 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
