Principal Design Quality Engineer - Remote

Overview

The Principal Design Quality Engineer will be a key member of the product development team at Cleerly, ensuring compliance with quality management standards and regulations for software medical devices.

In Short

• Lead design quality engineering for software development projects.
• Review and approve design documentation and validation plans.
• Ensure compliance with ISO 13485 and FDA regulations.
• Facilitate risk management activities throughout the product lifecycle.
• Collaborate with engineering teams on testing methodologies.
• Maintain accurate Design History Files for audits.
• Provide quality oversight in an agile development environment.
• Participate in design reviews and project meetings.
• Support investigation of design-related complaints.
• Design and drive team training in quality areas.

Requirements

• Bachelor’s degree in engineering or related discipline.
• 12+ years of experience in Design Quality within medical devices.
• Strong analytical and problem-solving skills.
• Practical knowledge of ISO 13485 and related processes.
• Experience with IEC 62304 and ISO 14971.
• Understanding of FDA Quality System Regulation.
• Experience with software development tools like GitHub.
• Strong communication skills for remote teamwork.
• ASQ certification is a plus.
• Willingness to travel to office locations occasionally.

Benefits

• Base salary range of $145,000 - $160,000.
• Eligible for a 15% target annual bonus.
• Comprehensive benefits package.
• Opportunities for professional development.
• Supportive remote work environment.