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, including complaint investigations, risk assessments, etc.
• Research new regulations for products, processes or the quality system
• Analyze data obtained using spreadsheet and statistical software
*Four year college degree in a technical discipline or equivalent work experience
*Strong Organizational skills
*Strong Analytical and problem-solving skills
*Experience with FDA QSR regulations and ISO standards preferred
*Computer skills including experience with word processing, spreadsheet and database software applications
Complaint evaluation work requires protective glasses and gloves when working with biologically contaminated returned products
Equal Opportunity Employer
Qualified candidates must be legally authorized to be employed in the United States. COOK does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.