Quality Engineering Manager- Post Market at Cook Inc. (Bloomington)

Posted in General Business 13 days ago.

Type: Full-Time
Location: Bloomington, Indiana

Job Description:

Quality Engineering Manager- Post Market

Requisition ID 2024-14838

Posting Date 19 hours ago (7/9/2024 10:58 PM)

Job Location(s) Bloomington IN United States

Travel Less than 10%

Position Type Full Time

Company Cook Inc - Bloomington

Category Quality


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.


Apply for this job online Apply


Share the job posting with a friend Refer

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.

Share on your newsfeed

"We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class."

Cook will consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state/province and local law.

More jobs in Bloomington, Indiana



Indiana University
More jobs in General Business

Fry's Food Stores