Quality Manufacturing Engineer

Posting Date 2 weeks ago(10/11/2021 8:09 AM)
Requisition ID
2021-9618
Job Location(s)
Spencer IN United States
Travel
Less than 10%
Shift Type
First
Position Type
Full Time
Company
Cook Spencer
Category
Quality

Overview

In this role, the MQE will support Manufacturing Operations which includes, but is not limited to: investigating, documenting and disposition of non-conforming product/processes, driving implementation of corrective and/or preventive actions (CAPA) and provide quality guidance according to 21 CFR 820 and ISO 13485. The Manufacturing Quality Engineer will support the manufacturing departments and mentor others outside of the Quality department on best quality practices.

Responsibilities

- Support manufacturing by addressing quality issues, documenting and dispositioning non-conformances;
- Drive quality improvements through non-conformance investigations, CAPAs and projects;
- Use empowerment, trust and other strategies as appropriate to develop and motivate other areas of Cook;
- Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth;
- Escalate quality issues to members of management;
- Attend, present and provide data for meetings (Material Review Board, Quality Data Review, Management Review, etc.) to include project updates and reviews;
- Report on progress of various projects and tasks;
- Participate in third party audit activities, including activities to assess and update the quality system in response to those audits.
- Ability to analyze complex data to make data driven decisions.
- Ability to assess risks and benefits in order to provide recommendations to support production activities (ie. Change Orders, validation support, system breech, etc.).

Qualifications

- Bachelor's degree in Engineering, Policy Analysis, Physical Sciences, or related area.
- Minimum 2 years of experience working in a Medical Device or Life Sciences Quality Management System (preferred).
- Proficient in quality tools including but not limited to: Data/Statistical Analysis, Root Cause Analysis, Fault Tree Analysis (FTA), Fishbone, etc. (preferred)
- Proficient in Microsoft Office and in desktop and mobile technology.

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