Quality Engineer - Post Market, Supplier & CAPA

3 months ago(10/16/2017 3:26 PM)
Requisition ID
Job Location(s)
Winston-Salem NC United States
Less than 10%
Position Type
Full Time
Cook Winston-Salem


The primary purpose of the Quality Engineer (Post Market, Supplier & CAPA) position at Cook Winston-Salem is to develop, implement and review quality engineering activities, including verification and validation, complaint investigations, quality system investigations and product quality issues.


• Participate on Corrective Action Preventative Action (CAPA) teams, providing guidance in application and use of quality tools
• Assist with the investigation, risk assessment and resolution of product quality and quality system issues
• Implement, support and maintain pre- and post-production quality activities
• Research new regulations for products, processes or the quality system
• Analyze data obtained from validation activities using spreadsheet and statistical software


• Four year college degree in a technical discipline or equivalent work experience
• Experience with FDA QSR regulations and ISO standards preferred

• Computer skills including experience with word processing, spreadsheet and database software applications


Physical Requirements:

• Complaint evaluation work requires protective glasses and gloves when working with biologically contaminated returned products


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