Job Description
Overview
Elevate quality standards in medical devices at Myant as a Senior Quality Assurance Specialist. Focus on compliance and risk management while enhancing health technology solutions.
Myant is seeking a Senior Quality Assurance Specialist to strengthen our QMS within a highly regulated medical device setting. With a focus on global ISO standards, you will ensure our products meet rigorous safety and quality benchmarks. This role intersects with various teams, including Engineering and Operations, to facilitate comprehensive quality oversight.
Key Responsibilities
- Ensure QMS compliance with ISO, MDSAP, and FDA
- Conduct risk management according to ISO 14971
- Manage design control processes for SaMD products
- Oversee validation and quality governance strategies
- Lead CAPA initiatives and nonconformance management
Requirements
- Bachelor’s degree in a relevant technical field