Quality Assurance Specialist
4 weeks ago
The Quality Engineer serves as the quality mentor and/or reviewer for all CAPA and RIC activities, ensuring compliance with external and internal quality standards. Key responsibilities include:
- Performing work per external and internal quality standards
- Interfacing with internal and external groups on quality-related issues
- Conducting risk-based decision making and effective resolution of issues
- May interface with internal or 3rd party audits
- Planning, reviewing, and approving change requests
- Performing quality assessment of root cause analysis of product or process CAPAs
- Mentoring CAPA owners in the use of root cause investigation tools and appropriate implementation activities
- Driving continuous improvement efforts through facilitating, leading, and collaborating with cross-functional teams
- Providing leadership in the understanding of medical device regulations and best practices
- Managing conflict resolution as it relates to technical situations
- Maintaining all training requirements for the position, while seeking out opportunities for continuous development and growth
- Adhering to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements
To be successful in this role, you will need:
- An engineer degree or a technical life science degree
- Demonstrated knowledge of medical device regulation (ISO 13485, 21 CFR) 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
This role will work under general office environmental conditions, including time in manufacturing environment and biohazard lab. Occasional travel may be required.
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