Quality Engineer 2, Manufacturing

About the role

The Quality Engineer at Cook Inc. serves as the lead quality representative for 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 (e.g., qualification, process capability, sampling plans, validation, etc.)
• Perform investigation of product nonconformance/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-functional 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
• Work and interact effectively and professionally with and for others throughout various levels of the organization
• Strictly adhere to safety requirements

Requirements

• Bachelor’s degree in engineering
• Legally authorized to be employed in the United States (Cook does not intend to provide sponsorship for employment visa status for this position)
• Demonstrates knowledge of medical device regulation (ISO 13485, 21 CFR) and risk management (ISO 14971)
• 3–5 years of experience
• 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 (Word, Excel, PowerPoint, and Outlook)
• Strong organizational skills
• Critical thinking and attention to detail
• Excellent verbal communication and technical writing skills

Physical Requirements

• Works under general office environmental conditions, including time in a manufacturing environment and biohazard lab
• Sitting for extended periods; utilizes close visual acuity for working with computers and equipment
• Occasional travel may be required