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. In addition to CAPA, this position is expected to provide leadership, oversight, and or monitoring for other Quality Systems such as Nonconformance Investigation/Containment and Field Action Assessment Request.
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 withminimal supervision.- Ability to remain calm and receptive in fast paced situations.
Qualifications- 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.- Previous leadership experience, 5 years preferred.•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
- Works under general office environment conditions.- Utilizes close visual acuity for working with computers and equipment.- Frequently required to stand, walk, and hear.- Occasionally lifting with minimal exertion during shift.
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What We Do
At Cook, we are building our future on Invention, Connection, People, and Community.
As a privately owned company, we can look at the world our own way and do what we feel passionate about. What are we passionate about? That’s simple: Making unique, quality products and connecting with people to improve lives on both sides of the device.
Central to our focus on building deep connections is our belief in the importance of identifying innovative solutions to help customers, patients, employees, and communities thrive. We understand that our ongoing success will come from creating inclusive, supportive, and healthy environments where we can prosper together. Our people are our greatest asset and are at the heart of everything we do. Come build with us.
