Software QA (Product & Regulatory)
PhysIQ is a transformational leader in applying highly sophisticated technology to solve some of the most pressing problems in healthcare. More specifically, we are forging the frontier of healthcare delivery at the intersection of mobile technology and artificial intelligence. Our team is comprised of veteran technologists and world-class data scientists and our solutions set the market standard for scalability and sophistication. Furthermore, we are implementers with a proven track record of transforming an audacious technological vision into mission-critical solutions for our customers.
- Our core values are simple and are defined by integrity, passion and relentless drive toward solving the impossible.
- We are a team in its purest definition. We all pull on the rope together, in the same direction, with the same intensity.
- Our customers and their patients depend on us to deliver technology that will forever change healthcare. We are literally keeping people out of the hospital. We are changing lives.
In our world, amazing things only happen when people make them happen. If you want to make things happen and do it with a world-class of team of visionaries and doers, we encourage you to apply.
PhysIQ is looking for a Software QA Engineer who will be engaged in the product development and regulatory process. The job involves ensuring the quality of a Software as a Medical Device (SaMD) product throughout the requirement, engineering, V&V (Validation and Verification), and release phases. The role requires performing and documenting components of the quality assurance tasks, and conforming to the organization’s quality management system (QMS).
- Hands-on Engineering to solve problems and provide solutions
- Review product design documentation to ensure that requirements stated are correct, unambiguous, and verifiable
- Define test methods and create test plans for new or updated software projects to determine if the software will perform accurately and reliably according to documented requirements
- Execute test plans and create test reports to describe program evaluation, testing, and correction (i.e., validation activities)
- Identify, record, document thoroughly and track bugs
- Recommend design improvements or corrections to engineers throughout the development process
- Identify and utilize existing testing tools that facilitate data gathering and test method execution
- Track quality assurance metrics, like defect densities and open defect counts
- Participate in complaints / nonconformance / CAPA team meetings with Product, Quality, and Customer Success functional areas
- Assist in establishing and measuring compliance with organization’s quality management system including audit scheduled tasks, audit preparation, and internal audit execution
- Bridge responsibilities in ensuring adequate risk assessment of software products and traceability with design control
- Bachelor’s Degree in electrical engineering, Computer engineering or equivalent technical Degree; or equivalent combination of education and experience
- Excellent analytical skills
- High level of initiative with ability to self-manage
- Strong interpersonal skills with ability to work both independently and as part of a team
- Excellent written and verbal communication skills
- Two (2) years Quality functional area experience in medical device industry preferred
- Functional knowledge of FDA regulations (21 CFR 820; Quality System Regulation) and appropriate industry standards for quality (ISO13485), life-cycle (IEC62304), and Risk Management (ISO14971) preferred