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Cook Medical is Hiring a Quality Assurance Manager- Manufacturing Quality Engineering Near Bloomington, IN
OverviewThe 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 with
minimal supervision.
Ability to remain calm and receptive in fast paced situations.
Qualifications
Bachelor's degree in Engineering
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