Job Description

Noah Medical is seeking a Recalls & CAPA Manager to drive innovation and product leadership in medical robotics. This role involves managing the CAPA process, handling product recalls, leading cross-functional teams, reporting on quality metrics, improving the quality system, ensuring regulatory compliance, and collaborating with various stakeholders.

Responsibilities

• Develop and maintain the CAPA process
• Manage product recall processes
• Lead and coordinate CAPA/Recalls/Project teams
• Report on quality metrics
• Support defining and implementing the quality management system
• Stay up-to-date on global regulations
• Collaborate with senior management and stakeholders

Requirements

• Bachelor's degree in an engineering discipline
• 7+ years of RA/QA experience in the medical device field
• Knowledge of regulatory requirements (FDA, CFDA, EU MDR, EMA, ISO)
• Understanding of quality management systems (GMP, GCP, ISO 13485)
• Experience with internal and 3rd party audits
• Understanding of medical device design, manufacturing, and field service processes
• Strong communication skills

Benefits

• No benefits