Job Description
Join Myant as a Senior Quality Assurance Specialist and elevate quality standards in medical devices. Focus on compliance and risk management while enhancing health technology solutions in a regulated environment.
This senior role is pivotal for strengthening the Quality Management System (QMS) at Myant. You'll ensure adherence to global ISO standards while managing design control processes for Software as a Medical Device (SaMD) products. Your impact extends across Engineering and Operations teams to ensure our products consistently meet safety and quality benchmarks.
Key Responsibilities:
• Ensure QMS compliance with ISO, MDSAP, and FDA
• Conduct risk management aligned with 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
...
This senior role is pivotal for strengthening the Quality Management System (QMS) at Myant. You'll ensure adherence to global ISO standards while managing design control processes for Software as a Medical Device (SaMD) products. Your impact extends across Engineering and Operations teams to ensure our products consistently meet safety and quality benchmarks.
Key Responsibilities:
• Ensure QMS compliance with ISO, MDSAP, and FDA
• Conduct risk management aligned with 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
...