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Quality Assurance Manager

2 months ago

Spencer, United States Cook Group Full time

Overview:

The Quality Assurance Manager at Cook Capital Equipment 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 SOPs to support improved processes and compliance

Provide quality expertise and leadership to management and operational personnel

Actively assure operational observance to compliance obligations to include, regulatory, contractual, and SOP driven requirements

Actively look for ways to improve quality processes and procedures

Attend, present and provide data for meetings to include project updates and reviews

Participate in hiring, interviewing and onboarding process of new hires

Responsible for performance management and annual reviews of direct reports

Authorization of weekly time sheets

Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth

Develop plans to evaluate improvement projects

Qualifications:

Bachelor's degree in Engineering or Life Science or equivalent experience

Minimum 3 years experience in a regulated industry, preferably in a medical manufacturing environment

Minimum 3 years experience working with quality management system

Previous leadership experience

Proficient in Microsoft Word/Excel/Project/Outlook, JBase, Livelink, Business Objects

Physical Requirements:

Works under general office environment conditions

Utilizes close visual acuity for working with computers and equipment

Frequently required to stand, walk, and hear

Occasionally required to lift up to 20 pounds