Quality Engineer 1, Post Market

The Quality Engineer, Post Market at Cook Incorporated serves as the lead quality representative of certain product lines within product development, manufacturing, post-market surveillance, and/or CAPA.

• Perform work per external and internal quality standards
• Interface with internal and external groups on quality-related issues
• Support product development and transfer to manufacturing
• Facilitate development and implementation of production controls. (e.g. qualification, process capability, sampling plans, validation, etc.)
• Perform investigation of product non-conformance/complaints, root cause analysis, monitoring/trending of process and product, and escalation of identified issues
• Plan, review, and approve change requests
• Execute risk assessment as needed and facilitate development and completion of risk file documentation
• Conduct Risk-based decision making and effective resolution of issues
• Lead or support CAPAs as necessary
• May interface with internal or 3rd party audits. (e.g. FDA, Notified Body, etc.)
• Drive continuous improvement efforts through facilitating, leading, and collaborating with cross function teams including quality, engineering, production, clinical, and regulatory affairs
• 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

• Bachelor's degree in Engineering 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