Genalyte is redefining how physicians order, fulfill and interpret laboratory test results in a way that meets the demands of digital consumers. We are creating a brand-new model that requires top engineering talent to define the user experience across all areas of the stack of our product and service offering.
We are looking for a Software QA Engineer that will collaborate between our software teams and our hardware QA. This is a rare opportunity to put your unique finger print on a high potential start-up that will profoundly impact millions of individual's interactions with a core capability of the healthcare system. Laboratory tests play a role in 70% of all medical decisions made. The creativity you bring to this role will likely impact your future experiences with the healthcare system as well as the experiences of your friends, family and the broader community.
What you'll do:
- Lead the software team in the execution of design control activities with a focus on new product development, quality planning, and risk management to positively impact the safety and efficacy of software products and applications.
- Provide quality oversight and guidance to medical device software and firmware design activities, ensuring adherence to company procedures and applicable ISO 13485:2016 and FDA design control (820.30) requirements.
- Lead and facilitate software and process risk management related activities including facilitating software risk assessments, code reviews, and failure mode and effects analysis (FMEA) with cross functional teams.
- Lead the implementation of the SDLC and newly developed software procedures, while ensuring all new software development processes and procedures are fully implemented and understood throughout the organization.
- Maintain the GxP computerized system inventory and oversee computer system validation (CSV), including software tool validation activities.
- Actively participate in software product design reviews and design transfer activities for new and existing instrument and consumable products intended to be commercially marketed or utilized in a CLIA lab environment.
- Partner with the QA department to conduct internal audits of the software development process per internal processes, ISO 13485:2016 and 21 CFR 820.
- Represent the software quality assurance team in quality system audits and inspections by regulatory agencies and applicable third parties.
- Bachelor's degree or higher in a scientific field, 5+ years related software development experience, preferably in medical device software, pharmaceutical, or in vitro diagnostic software.
- 8+ years’ experience in medical device software quality assurance, software testing, including medical device software verification & validation.
- Hands-on experience developing and implementing medical device software design control (21 CFR 820.30) related processes, preferably in a startup environment.
- Working experience and knowledge of Quality System Regulations and International Standards such as Part 11, 21 CFR 820, ISO 13485, ISO 14971, EN 62366, EN62304 and in vitro diagnostics software regulations. IVDR experience is a plus!
- Strong technical writing skills, including the ability to write software verification and validation procedures, software development plans, bridge study reports, and code review record keeping.