Software Quality Assurance Engineer

Software Quality Assurance Engineer We are seeking an experienced Software Quality Assurance Engineer to own the full lifecycle of our regulated software products - from requirements through production release. This is a multi-faceted role that sits at the intersection of software quality, regulatory compliance, and cross-functional collaboration. You will serve as the backbone of our software development process, ensuring the efficient delivery of secure, safe, and effective software through disciplined application of our software quality processes. Key Responsibilities Software Development Lifecycle Management Author, maintain, and manage software development plans and software validation plans for medical device and production software in accordance with standards and internal procedure Partner with business analysts to elicit, analyze, and document software change requests and requirements, ensuring clear traceability from business need through implementation Manage traceability of change requests in the requirement management platform, maintain accurate linkage between requirements, design specifications, test plans, and risk items throughout the development lifecycle Conduct and manage impact assessments for software changes, evaluating scope, risk, and regulatory implications prior to development Author and update risk management documentation including software failure mode analyses, risk analyses, and risk-benefit assessments Partner with software engineering team to ensure all phase-appropriate deliverables are completed on schedule, including development and validation plans, requirements specifications, design specifications, risk assessments, test plans, and traceability matrices Drive lifecycle phase gates, confirming entry and exit criteria are met before progression and escalating gaps proactively Maintain document control practices to ensure all regulated artifacts are revision-controlled, reviewed, and approved in accordance with quality system requirements Release Management Act as release manager of software documentation, owning the end-to-end pre-release verification and validation completion process Coordinate across stakeholders including product development, software engineering, and process development teams to confirm all V&V activities are completed and prior to release authorization Track and report release readiness status, identifying and resolving open items that could block release or introduce unacceptable risk Facilitate release review meetings and ensure all required signoffs, approvals, and records are in place prior to production deployment Manage multiple concurrent software releases in parallel, maintaining visibility and control across all active workstreams without compromising quality or compliance Audit Support Collaborate with the Quality team to prepare for internal and external audits, ensuring software lifecycle deliverables, risk assessments, and supporting evidence are complete, accurate, and audit-ready Serve as a subject matter expert during audits for software development processes, demonstrating compliance of deliverables against applicable SOPs, work instructions, and regulatory standards Review and assess deliverables and artifacts against internal SOPs and work instructions, identifying and remediating gaps ahead of audit activities Support audit findings remediation by identifying root causes, defining corrective actions, and tracking closure of any software-related observations or nonconformances Regulatory Alignm ent Own and maintain internal procedures (SOPs and work instructions) governing software development, validation, risk management, and release processes Monitor changes to applicable regulatory standards and guidance including IEC 62304, ISO 14971, FDA medical device and production software guidance - and translate updates into actionable procedure revisions Partner with Quality, Regulatory Affairs, and software teams to review, revise, and gain approval for updated procedures in a timely manner Communicate procedure changes to affected stakeholders and support training or awareness activities as needed to ensure consistent implementation Required Qualification Bachelor’s degree in computer science, biomedical engineering or related discip line.Minimum of 3 years of relevant experience working in a highly regulated environment, software development, or software quality. Proficiency with ISO 14971 risk management principles as applied to software Experience supporting regulatory submissions involving software components (510(k), De Novo, or equivalent Preferred Qualifications Strong understanding of SiMD (Software in a Medical Device) and SaMD (Software as a Medical Device) regulatory requirements, Design History Files (DHFs) including applicable FDA guidance documents Deep knowledge of Knowledge of FDA QSRs, ISO 13485 Design Control Procedures, ISO 14971 and IEC 62304 including software safety classification, development planning, and maintenance processes Experience authoring software risk documentation, including software failure modes and effects within a regulated environment Experience supporting regulatory submissions involving software components (510(k), De Novo, or equivalent) Proven track record managing software releases in a regulated medical device environment, including impact assessments and cross-functional stakeholder coordination Experience supporting internal or external audits, including preparing deliverables for review and serving as an SME for software development processes Experience owning or significantly contributing to regulated procedure (SOP/WI) authoring and revision processes Working knowledge of requirements management tools such as Jira, Jama, or equivalent Strong familiarity with V&V documentation including test plans, test protocols, and traceability matrices Excellent written and verbal communication skills, with the ability to translate technical and regulatory requirements into clear, compliant documentation Demonstrated ability to manage multiple simultaneous software development projects and releases without loss of quality or compliance Familiarity with CAPA processes and audit finding remediation workflows Show more Show less