Enhance product quality at Myant as a Senior Quality Assurance Specialist responsible for compliance in the fast-evolving medical device landscape. Utilize your skills in risk management, audit readiness, and quality systems.
In this senior individual contributor role, you will focus on amplifying Myant’s Quality Management System (QMS) to meet stringent medical device regulations like ISO 13485 and FDA QMSR. Your leadership will extend to managing risk evaluations, supporting regulatory audits, and guiding teams in rigorous design control practices. A collaborative approach will be essential in interfacing with Engineering and Operations to fuse quality with innovation.
Key Responsibilities:
• Maintain QMS compliance across multiple regulatory frameworks
• Lead risk management according to ISO standards
• Oversee design control processes and validation governance
• Manage CAPA and nonconformance investigations
• Facilitate internal and external audits effectively<...