Software Quality Engineer

Role overview A Software Quality Engineer supports the development, implementation, and maintenance of software-specific QMS processes for IVD and digital products, spanning the SDLC, software risk management, and cybersecurity. Reporting to IVD Regulatory and Quality leadership, the role acts as the quality partner embedded with software development and bioinformatics teams, ensuring engineering work and documentation meet regulatory and standards expectations.

Responsibilities - Execute assigned software development quality activities and help build out SDLC QMS processes - Provide quality review and process oversight for software design-control artifacts, including requirements, architecture, code reviews, and V&V documentation - Participate in development and review of design and development file documentation across the product lifecycle - Serve as the quality representative for software risk-management activities - Support validation of non-product software tools used in operations, testing, and the quality system - Investigate and resolve software-related nonconformances, deviations, and CAPAs - Provide quality input on cybersecurity design controls, risk management, vulnerability management, and post-market activities - Support internal and external audits by preparing software-related objective evidence and assisting with responses - Monitor evolving FDA, international, and standards expectations and recommend updates to processes and documentation

Requirements - Bachelor's or advanced degree in a relevant scientific or technical field such as computer science, engineering, or bioinformatics - 6+ years of software QA experience, including 4+ years in medical device or FDA-regulated software development - Practical experience with design controls, ISO 13485, ISO 14971, and IEC 62304 - Experience with Software as a Medical Device or medical devices containing software, including design control procedures and SDLC in regulated environments - Experience supporting regulatory submissions and audits - Ability to manage multiple projects and priorities in a fast-paced environment

Nice to have - Certified Software Quality Engineer (CSQE) credential

Benefits and work setup - Fully remote position with a standard schedule of Monday through Friday, 9 AM to 5 PM EST - Budgeted pay range of $111,249–$122,620 USD