Quality Engineer

Posting Date 2 months ago(12/2/2021 3:14 PM)
Requisition ID
Job Location(s)
Spencer IN United States
Less than 10%
Position Type
Full Time
Cook Capital Equipment


The Quality Engineer serves as the quality mentor and/or reviewer for all CAPA activities, will investigate product and process nonconformances, and will investigate service and product complaints.


- Perform work per external and internal quality standards.
- Interface with internal and external groups on quality-related issues.
- Perform investigation of product non-conformances and/or processes and determine disposition.
- Ability to analyze complex data to make data driven decisions.
- Conduct Risk-based decision making and effective resolution of issues.
- Execute risk assessment as needed and facilitate development and completion of risk file documentation.
- Participate in third party audit activities, including activities to assess and update the quality system in response to those audits.
- Perform quality assessment of root cause analysis of product or process CAPAs.
- Mentor CAPA owners on the use of root cause investigations tools and appropriate implementation activities.
- Drive continuous improvement efforts through facilitating, leading, and collaborating with cross functions teams.
- Provide leadership in the understanding of medical device regulations and best practices.
- 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.


 - Bachelor's degree in Engineering Technical Life Science.
- Demonstrates knowledge of medical device regulation (ISO 13485, 21CFR) and risk management (ISO 14971).
- Professional certification (e.g., ASQ, Six Sgma, etc.) preferred, but not required.
- 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.

- Qualified candidates must be legally authorized to be employed in the United States. 


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