Quality Assurance Engineer, Sr.

• Leads the ongoing implementation of Software Quality Management System (QMS) in conformance with US FDA Quality System Regulations and ISO 13485 Design Controls, through the integration of internal and external/medical device industry best practices.
• Responsible for the administration of the QMS software.
• Collaborates with software development teams in the creation of Design History Files (DHFs) including software development plans, software verification and validation plans, software requirements specifications, software architecture and design documents, design and code reviews, software Risk Management File (RMF), test protocols and reports, traceability matrices.
• Conducts investigations and provides corrective and preventive actions based on analysis and review. Provides and implements effective solutions that will drive continuous and measurable improvements.
• Integrates ISO 14971, risk management and IEC 62366 usability engineering activities with Glidewell/Prismatik processes.
• Mentors and provides direction to software development teams in design controls and lead risk management activities.
• Fosters and maintains organizational compliance to the quality system including ongoing training and education on software QMS and Prismatik framework.
• Provides CAPA, complaints, audit and overall QMS support in regards to software.
• Performs other related duties and projects as business needs require at direction of management.

• Bachelor’s degree in Computer Science, Software Engineering, Informatics, Biomedical, or related technical field or equivalent practical experience.
• Minimum of eight (8) years of experience in software design assurance in the FDA QSR/ISO 13485 medical device industry.
• Experience with the application of IEC 62304 (Medical Device Software Lifecycle Processes), ISO 14971 (Risk management) and IEC 62366 Usability Engineering.
• Experience with Agile software development methodologies like Scrum and Kanban.
• Experience with other than embedded software development areas, such as web development.
• Previous experience with digital health, Health IT or mobile medical applications required.
• Previous experience with cloud-based software preferred.
• Knowledge of CAD/CAM and AI/ML a plus.

• Advance knowledge with development and test requirements with recognized standards (ISO 13485).
• Demonstrated knowledge of the application of regulatory requirements for wellness, low-risk and high-risk software applications using a scalable approach to the Prismatik practices and the QMS.
• Demonstrated knowledge and understanding of software development, including cloud computing.
• Demonstrated ability to implement and improve Software QMS processes.
• Demonstrate knowledge of group software development methods (Agile Process and Scrum Method).
• Advance knowledge on writing, executing and monitoring automated test suites using a variety of technologies (Selenium, WebDriver, JavaScript and Nodejs).
• Demonstrated knowledge of AWS architecture and tools (EC2, Lambda, RDS, Dynamo DB, RedShift, SQS, S3, API Gateway, Kinesis, and CloudWatch).
• Demonstrated time-management skills to complete assignments while meeting critical deadlines.
• Ability to contribute effectively as a member of a team and work cohesively as a part of a team.
• Possess a strong attention to detail and accuracy.
• Proficient knowledge of general office procedures and office machines.
• Ability to effectively prioritize duties and efficiently complete responsibilities.
• Ability to work beyond normal business hours to meet critical deadlines and resolve emergency issues.
• Ability to travel within company premises occasionally, both domestically and internationally, depending on project requirements.

Pay:$110K-$135K