What are the responsibilities and job description for the Quality Assurance Specialist position at Mermaid Medical Group?
About Mermaid Medical Group
As a global leader in the MedTech industry, Mermaid Medical Group is seeking an experienced Quality Engineer to support its rapid growth in North America.
We are dedicated to developing, manufacturing, and distributing medical devices that make a positive impact on people's lives. Our mission is to provide innovative solutions for diseases in the vascular system and other interventional radiology applications.
The successful candidate will be responsible for maintaining, improving, and developing our Quality Management System, working with corrective actions and helping reduce failure rates and cost of poor quality.
Key Responsibilities:
- Maintain Quality Systems documents, such as SOPs and Work Instructions, in a proactive manner.
- Partner with Engineering and Operations to define process improvements.
- Conduct internal audits and support external audits.
- Evaluate bioburden testing completion according to schedule.
- Oversee the Product Release Processes and device history records review.
- Compile QMS Data for Management Review and Data Analysis.
- Support Risk Management, Design Review, and other Device History File-related activities.