Quality Engineering Manager- Post Market

Requisition ID 2024-14838
Posting Date 2 weeks ago(7/9/2024 3:58 PM)
Job Location(s)
Bloomington IN United States
Less than 10%
Position Type
Full Time
Cook Inc - Bloomington


The Post Market Quality Engineering Manager serves on a cross functional team, ensuring the adequacy, suitability and compliance of Quality Management System processes. Manages day-to-day quality operations and provides leadership and direction to the functional team.


- 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 complaint management process in the Quality Management System to ensure meeting FDA 21 CFR's 820, 806, and 803, and 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.
- Authorization of weekly time sheets, concur, PTO request, department specific documents.
- 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

- 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.


- Bachelor's degree in Engineering or Life Science
- Minimum of 5 years experience in a regulated industry, preferably in a medical manufacturing environment.
- Minimum 3 years experience working with quality management system.
- Previous leadership experience, 5 years preferred.
- 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 communicate.
- Occasionally lifting with minimal exertion during shift.


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