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Quality Assurance Manager
2 months ago
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