Quality Engineer - CAPA

Posting Date 2 weeks ago(3/25/2021 1:59 PM)
Requisition ID
Job Location(s)
Bloomington IN United States
Less than 10%
Position Type
Full Time
Cook Inc.


The CAPA Quality Engineer serves as the lead for CAPAs, QMS improvement, and QMS efficiency projects within CINC.


- Drive a variety of projects such as CAPA, Non-conformance investigation, and QMS improvement and efficiency projects.
- Perform quality review of CAPA and non-conformance investigation documentation.
- Be a mentor for the CAPA and non-conformance investigation processes.
- 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.

- 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.


- 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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