Overview

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

- 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. (. qualification, process capability, sampling plans, validation, - 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. (. FDA, Notified Body, - 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. Qualifications

**Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (., H-1B or TN status) of this employment position.** - Bachelors 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 (. ASQ, Six Sigma, 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.