Quality Engineer, CAPA - Bloomington
Bloomington
Overview:
The Quality Engineer serves as the quality mentor and/or reviewer for all CAPA and RIC activities.
Responsibilities:
- Perform work per external and internal quality standards
- Interface with internal and external groups on quality-related issues
- Conduct Risk-based decision making and effective resolution of issues
- May interface with internal or 3rd party audits. (e.g. FDA, Notified Body, etc.)
- Plan, review, and approve change requests
- Perform quality assessment of root cause analysis of product or process CAPAs
- Mentor CAPA owners in the use of root cause investigation tools and appropriate implementation activities
- 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
Qualifications:
- Engineer degree 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
Physical Requirements:
- 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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