Quality Engineer 2, Manufacturing

Cook Group • Bloomington, IN

2d

About The Position

The Quality Engineer at Cook Inc. serves as the lead quality representative of certain product lines within product development, m Next anufacturing, post-market surveillance, and/or CAPA.

Requirements

• Bachelors degree in engineering
• Demonstrates knowledge of medical device regulation (ISO 13485, 21CFR) and risk management (ISO 14971)
• 3-5 years of experience
• 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
• Proficiency in statistical, quality and continuous improvement methods and tools

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 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 work and interact effectively and professionally with and for others throughout various levels of the organization
• Must strictly adhere to safety requirements

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level