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 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