Manufacturing Quality Engineer 1

Cook Medical - Bloomington, IN

Full-time

Bloomington, IN

Merchant Wholesalers, Durable Goods

About the position

The Quality Engineer at Cook Medical serves as the lead quality representative for specific product lines, focusing on product development, manufacturing, post-market surveillance, and corrective and preventive actions (CAPA). This role is crucial in ensuring compliance with quality standards and regulations while driving continuous improvement initiatives across various teams.

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
• 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 various levels of the organization
• Strictly adhere to safety requirements

Requirements

• Bachelor's degree in a scientific discipline or equivalent experience
• 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

Nice-to-haves

• Professional certification (e.g. ASQ, Six Sigma, etc.) preferred