Position Overview
Join Myant as a Senior Quality Assurance Specialist dedicated to transforming health technology. Elevate product compliance and lead quality initiatives across diverse markets.
This senior-level position focuses on strengthening Myant's QMS while ensuring alignment with stringent global standards like ISO 13485 and FDA guidelines. Your responsibilities will encompass risk management, design control, and validation governance, crucial for maintaining high-quality medical devices and software-enabled products. By collaborating closely with teams, you will influence product lifecycle quality and contribute significantly to regulatory readiness.
Key Responsibilities:
β’ Drive QMS compliance with regulatory requirements
β’ Manage design control processes and governance
β’ Lead risk planning and evaluations
β’ Oversee enterprise validation strategy and audits
β’ Direct CAPA and nonconformance management
Requirements:
β’ Bac...