Quality Assurance Principal - Remote

Overview

The Quality Assurance Principal is responsible for supporting DeepHealth products and product development, along with the Quality Management System throughout the organization. This role involves collaboration across various functions to guide product development and ensure compliance with quality processes.

In Short

• Engage cross-functionally with Engineering, Clinical, and Marketing teams.
• Act as the Quality lead for design changes to existing products.
• Guide junior Quality Assurance team members.
• Manage product-specific Quality Management System processes.
• Integrate products due to corporate and/or product acquisitions.
• Ensure compliance with US and OUS standards and regulations.
• Participate in the development of junior staff.
• Collect and monitor quality metrics for Management Review.

Requirements

• Bachelor’s degree in a relevant field or equivalent experience.
• Minimum of 10 years working in a regulated industry.
• Strong knowledge of FDA Quality System Regulations.
• Knowledge of EU Medical Device Regulation and ISO standards preferred.
• Understanding of pre- and post-market clinical studies preferred.
• Participation in regulatory audits is a plus.
• Excellent written and oral communication skills.

Benefits

• Remote work opportunity.
• Domestic/international travel up to 15%.
• Supportive work environment.
• Opportunity for professional development.