Full-Time Senior Quality Engineer

Heartflow is a medical technology company revolutionizing coronary artery disease diagnosis and management. Their AI-driven, non-invasive cardiac test (Heartflow FFRCT Analysis) provides a 3D model of a patient's coronary arteries, visualizing blood flow impact.

Job Responsibilities:

• Support software releases with risk assessments and improved risk management processes.
• Collaborate with teams on quality project management.
• Manage internal and external audits, addressing non-conformities and driving change.
• Collaborate with external partners (regulators, representatives, importers, distributors).
• Input into risk management, ensuring risk identification and updates throughout the product lifecycle.
• Evaluate changes to standards and regulations.
• Support Quality System management and implementation.
• Support Corrective and Preventative Action (CAPA) processes and non-conformances.
• Train company staff on quality initiatives.
• Perform other duties as needed.

Skills Required:

• Experience with SaMD and AI/ML devices.
• Strong competency in ISO 13485, ISO 14971, 21 CFR 820.
• Risk management expertise (risk assessment, FMEA review).
• Project management skills.
• Excellent communication, writing, and editing skills.
• Proficiency in Word, Excel, and PowerPoint.
• Front-room audit experience.

Education & Experience:

• Bachelor's degree in science, engineering, or related field.
• 6-8 years of experience in medical device quality.
• Certified Quality Auditor (preferred).
• Experience with software as a medical device (SaMD), focusing on AI/ML.

What is the last date for applying to the job?

Which countries are accepted for this remote job?