Quality Assurance Manager - Cook Group

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 SOP’s 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