Engineer, Quality - Projects

Posting Date 3 weeks ago(5/10/2022 8:58 PM)
Requisition ID
2022-10170
Job Location(s)
Bloomington IN United States
Travel
Less than 10%
Position Type
Full Time
Company
Cook Inc.
Category
Quality

Overview

The Quality Engineer serves as the project manager for QMS improvement and efficiency project within CINC.

Responsibilities

- Drive continuous improvement efforts through facilitating, leading, and collaborating with cross function teams including quality, engineering, and production.
- Lead projects from start to finish including developing and reporting metrics to track progress.
- Perform work per external and internal quality standards.
- Interface with internal and external groups on assigned projects.
- May interface with internal or 3rd party audits. (e.g. FDA, Notified Body, etc.).
- Initiate and drive change requests.
- Provide leadership in the understanding of medical device regulations and best practices.
- Manage conflict resolution as it relates to technical situations.
- Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.
- Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.

Qualifications

• Engineer degree or a Technical Life Science degree
• Demonstrates knowledge of medical device regulation (ISO 13485, 21CFR) and risk management (ISO 14971)
• Professional certification (e.g. ASQ, Six Sigma, etc.) preferred
• Proficiency in statistical, quality and continuous improvement methods and tools
• Proficiency in the Microsoft Office suite of products (Word, Excel, PowerPoint, and Outlook) is required
• Strong organizational skills
• Critical thinking and attention to detail required
• Excellent verbal communication skills and technical writing

 

Physical Requirements:

• Works under general office environmental conditions, including time in manufacturing environment and biohazard lab
• Sitting for extended periods, utilizes close visual acuity for working with computers, equipment, etc.
• Occasional travel may be required

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