Description

Lead quality assurance and design assurance for Class III medical devices.

Responsibilities

• Support Class III IDE and PMA regulatory submissions.
• Drive quality activities within New Product Development (NPD) cycles.
• Maintain the Design History File (DHF) and all related technical documentation.
• Ensure compliance with ISO 13485 and ISO 14971 standards.

Required Skills

• 10+ years of experience working with Class III medical devices.
• 5+ years of experience specifically in design assurance for Class III devices.
• Direct experience supporting Class III IDE and PMA submissions.
• Deep knowledge of FDA regulations for medical devices.
• Proven track record with NPD (New Product Development) activities.
• Expertise in maintaining DHF (Design History File) documentation.
• Working knowledge of ISO 13485 quality management systems.
• Working knowledge of ISO 14971 risk management.
• Bachelor's degree or equivalent graduate education.

Key Skills

Education

ANY GRADUATE