Senior Quality Engineer

Summary

Join Heartflow, a medical technology company revolutionizing precision heartcare, as a Senior Quality Engineer. You will be part of the Quality and Regulatory Affairs team, contributing to the development and maintenance of our AI-driven cardiac test. This role requires 6-8 years of experience in medical device quality, with a strong understanding of quality requirements and regulations. You will collaborate with cross-functional teams, manage audits, and support risk management activities. The position offers a competitive salary, cash bonus, and stock options, and is remote.

Requirements

• Experience working with SaMD and AI / ML devices a must
• High competency of ISO 13485, ISO 14971, 21 CFR 820
• Experience with risk management activities including risk assessment and review of FMEAs
• Project management skills
• Demonstrated team collaboration
• Excellent communication, writing, and editing skills
• Strong Word, Excel, and PowerPoint skills
• Front room audit experience required
• Bachelor’s degree in science, engineering, or equivalent
• 6-8 years of experience in the medical device industry with a focus on Quality
• Experience with software as a medical device with a focus on artificial intelligence and machine learning

Responsibilities

• Support frequent minor software releases by performing risk assessments and aiding regulatory teams in establishing better processes for risk management
• Collaborate with cross-functional teams to drive quality project management activities
• Manage audits (internal and external) and communicate non-conformities assessed to greater team, driving the implementation of change when needed
• Collaborate with external partners including regulatory agencies, authorized representatives, importers and distributors to support management of Quality Systems
• Provide input to the risk management process to ensure risks are identified and updated during the product life cycle
• Conduct Quality assessment of changes to standards and regulations and communicate cross-functionally
• Support and drive Quality System management and implementation of changes
• Support Corrective and Preventative Action (CAPA) processes and non-conformances (NCRs) through identification of root cause
• Train company in support of Quality initiatives
• Other relevant duties as assigned
• Ability to work in a fast-paced adaptive environment, self-starter, and strong team player

Preferred Qualifications

Certified Quality Auditor a plus

Benefits

This position has an estimated base salary of $115,000 - $160,000, a cash bonus, and stock options