Join Myant as a Senior Quality Assurance Specialist, focusing on regulatory compliance and quality systems in medical devices. Drive innovation by ensuring product safety and effectiveness.
In this senior-level role, you will be pivotal in enhancing Myant’s Quality Management System in line with international standards. Your strong background in ISO 13485 and FDA regulations will be vital for maintaining compliance and supporting product lifecycle quality. Collaborate with cross-functional teams to embed quality practices in all aspects of product development.
Key Responsibilities:
• Lead QMS alignment with regulatory standards
• Conduct risk assessments and management
• Govern design control and validation processes
• Oversee CAPA and nonconformance procedures
• Manage supplier quality and external partnerships
Requirements:
• Bachelor’s degree in Engineering or Life Sciences
• 7+ years of relevant experience in quality assurance
• Extensive knowledge ...