CG
Director, Quality Assurance
full-time•Bloomington
About this role
Overview
The Director, Quality Assurance at Cook Incorporated assists the VP, QA in leading the Company in all matters relevant to the QMS as established by customer, regulatory and external standards requirements. This position is responsible for ensuring that the QMS are effectively understood, implemented and maintained at all levels and monitored for effectiveness in meeting quality objectives, and improved when objectives are are not met.
Responsibilities
• Oversee the adequacy and maintenance of the QMS in meeting the requirements of the Cook entities and liaise with external accredited agencies • Ensure that reports are made to Management with Executive Responsibility (MER) on its performance, status and areas that require improvement • Ensure that awareness of regulatory and customer requirements is communicated with both staff and Management • Assist in establishment, maintenance and adequacy of the QMS• Foster and maintain a workplace culture respectful and supportive of individual differences• Must work and interact effectively and professionally with and for others throughout various levels of the global organization• 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
Qualifications
• Bachelor's degree in related field or experience of such kind and amount as to provide a comparable background• Master's degree preferred• 10+ years of related industry experience• 5+ years in a leadership role
Physical Requirements:
• This position requires on-site support and may on a periodic basis include requirements to travel to other locations domestically and internationally• General office environment• Sitting for extended periods
• Requires close visual acuity when working with computers, etc.
What you'll do
- The Director of Quality Assurance oversees the Quality Management System (QMS) to ensure compliance with customer and regulatory standards. This role involves reporting on QMS performance and fostering a supportive workplace culture.
About Cook Group
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.
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Frequently Asked Questions
What does a Director, Quality Assurance do at Cook Group?
As a Director, Quality Assurance at Cook Group, you will: the Director of Quality Assurance oversees the Quality Management System (QMS) to ensure compliance with customer and regulatory standards. This role involves reporting on QMS performance and fostering a supportive workplace culture..
Is the Director, Quality Assurance position at Cook Group remote?
The Director, Quality Assurance position at Cook Group is based in Bloomington, Indiana, United States. Contact the company through Clera for specific work arrangement details.
How do I apply for the Director, Quality Assurance position at Cook Group?
You can apply for the Director, Quality Assurance position at Cook Groupdirectly through Clera. Click the "Apply Now" button above to start your application. Clera's AI-powered platform will help match your profile with this opportunity and guide you through the application process.