Quality Engineer, Post Market
Cook Medical
Date: 1 week ago
City: Bloomington, IN
Contract type: Full time
Overview
The Quality Engineer, Post Market at Cook Incorporated serves as the lead quality representative of certain product lines within product development, manufacturing, post-market surveillance, and/or CAPA.
Responsibilities
The Quality Engineer, Post Market at Cook Incorporated 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. (e.g. qualification, process capability, sampling plans, validation, etc.)
- 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. (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 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
- Bachelor's 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 (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
- Works under general office environmental conditions, including time in manufacturing environment and biohazard lab
- Sitting for extended periods, utilizes close visual acuity for working with computers, equipment, etc.
- Occasional travel may be required
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