Quality Manufacturing Engineer

Posting Date 3 weeks ago(10/5/2021 11:01 AM)
Requisition ID
2021-9659
Job Location(s)
Canton IL United States
Travel
Less than 10%
Shift Type
First
Position Type
Full Time
Company
Cook Inc.
Category
Quality

Overview

In this role, the MQE will support Manufacturing Operations which includes, but it not limited to: investigating, documenting, and disposition of non-conforming product/processes, driving implementation of corrective and/or preventative actions (CAPA) and provide quality guidance according to 21 CFR 820 and ISO 13485.

 

The Manufacting 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 devlop 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 Reveiw, etc.) to include project updates and reveiws;
• Report on progress of various projects and tasks;

• Particiapte 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 Breach, etc.)

- Must work and interact effectively and professionally with and for others throughout various levels of the global organization

- Must strictly adhere to safety requirements

- Must maintain company quality and quantity standards

- Must have effective communication skills and ability to work in a collaborative and independent work situations and enviornments with minimal supervision.

- Abilty to remain calm and receptive in fast paced situations.

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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