Software Quality Engineer
Verily
over 1 year ago
Boston, MA, USA +2 more
Senior
Base Salary
$123k - $189k/yr
Responsibilities
- Participate in the implementation of Software Quality Management System (QMS) in compliance with FDA and ISO standards.
- Support software development teams in creating Design History Files (DHF) and related documentation.
- Integrate risk management and usability engineering activities with software development processes.
- Guide teams in design controls and risk management activities.
- Provide ongoing training and support for compliance with the quality system.
Requirements
- BA/BS degree in Computer Science, Software Engineering, or a related field.
- 5 years of experience in software design assurance in the FDA QSR/ISO 13485 medical device industry.
- Experience with IEC 62304, AAMI TIR45, ISO 14971, and IEC 62366.
- Project management experience and ability to collaborate with software development teams.
Benefits
- Flexible work arrangements and resources for whole-person well-being.
- Competitive benefits package.
Tech Stack
MLflowRobot Framework
Categories
AI & MLTesting