Job Description
Become a Senior Quality Assurance Specialist at Myant and help shape the future of medical devices. Focus on compliance, risk management, and quality oversight in healthcare technology.
In this crucial role, you will strengthen Myant's Quality Management System (QMS) within a highly regulated environment. Your responsibilities will include ensuring compliance with global ISO standards and conducting risk assessments for Medical Device Software (SaMD). Collaborating with cross-functional teams, you will lead initiatives to uphold safety and quality for innovative health tech solutions.
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
• Minimum 7 years of quality assu...
In this crucial role, you will strengthen Myant's Quality Management System (QMS) within a highly regulated environment. Your responsibilities will include ensuring compliance with global ISO standards and conducting risk assessments for Medical Device Software (SaMD). Collaborating with cross-functional teams, you will lead initiatives to uphold safety and quality for innovative health tech solutions.
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
• Minimum 7 years of quality assu...