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- 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 leadership to management and operational personnel.- Responsible 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 to support operations.- Maintain the process in the Quality Management System to ensure meeting FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.- Attend, present and provide data for meetings to include project updates and reviews.- Participate in hiring, interviewing and on boarding process of new hires.- Responsible for performance management and annual reviews of direct reports. - Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.-Excellent problem solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision.
- 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- Bachelor's degree in Engineering or Life Science or experience of such kind and amount as to provide a comparable background.- Minimum of 5 years experience in a regulated industry, preferably in a medical manufacturing environment.- Minimum 3 years experience working with quality management system.- Previous leadership experience, 5 years preferred.- Proficient in Microsoft Word/Excel/Project/Outlook, JBase, Livelink, Business Objects.
- 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.
Top Skills
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.
