Job Description
A new health care company is looking for a Software Quality Assurance Engineer to work remotely. The ideal candidate will be a multi-tasker with a positive attitude. In this role, the Software Quality Assurance Engineer will make an impact by leading software quality assurance activities throughout medical device software life cycle, including creating software quality assurance plans and cyber risk assessment plans, performing software configuration management and change control activities, facilitating threat modelling and vulnerability assessments, writing reports, performing gap assessments against applicable regulations and industry standards.
Implements standard operating procedures for medical device software engineering, takes an active role in continuous improvement of the medical device software engineering process, including authoring, reviewing, and approving procedures, work instructions and templates. They will also determine software safety classification, software test readiness, software release readiness, and oversees medical device software development, maintenance, testing, release, safety, and security risk management and ensures compliance with applicable regulatory requirements and industry standards. The Software Quality Assurance Engineer is expected to be an active member of the software team during the whole software life cycle, with responsibility for reviewing and approving software requirements, software design, test procedures, test logs, test results, and providing insight to management regarding software project status and software quality metrics.
Required Skills & Experience
Must Haves:
* Bachelor's degree in computer science or a related field (information systems)
* 3 years of experience in medical device software quality
Nice to Have Skills & Experience
Plusses:
* Working knowledge of medical device software regulations (FDA, EU and other agencies) as well as medical device related standards such as ISO 13485, ISO 14971, IEC 62304 amongst others
* Working knowledge of C language.
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.