Senior Quality Engineer

The Senior Quality Engineer is part of the Quality and Regulatory Affairs team. The individual has 6-8 years of experience in medical device quality with an understanding of quality requirements and can resolve a wide range of issues while maintaining compliance with regulations and standards. This individual will play a key role in HeartFlow quality activities involving cross-functional collaboration for product changes, as well as maintenance of quality management system documentation. #LI-Remote; #LI-IB1

Job 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

Skills Needed:

• 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.

Educational Requirements & Work Experience:

• Bachelor’s degree in science, engineering, or equivalent
• 6-8 years of experience in the medical device industry with a focus on Quality
• Certified Quality Auditor a plus
• Experience with software as a medical device with a focus on artificial intelligence and machine learning

This position has an estimated base salary of $115,000 - $160,000, a cash bonus, and stock options. #LI-IB1; #LI-Remote