Manager, Quality Engineering Post Market

Posting Date 17 hours ago (11/18/2020 1:55 AM)

Requisition ID 2020-8167 Job Location(s) Bloomington IN United States Travel Less than 10% Position Type Full Time Company Cook Inc. Category Quality

Overview

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.

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 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
supervision.

Qualifications

- Bachelor's degree in Engineering or Life Science or experience of such kind and amount as to provide a comparable background.
- 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: