Quality Engineer 2, Manufacturing

Cook Group•Bloomington, IN

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 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

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