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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Staff SW QA Engineer - **Company:** Dexcom, Inc. - **Location:** San Diego, CA, United States (Remote available) - **Experience:** Experienced - **Salary:** $116,600.0 - $194,400.0 - **Contract:** Permanent contract - **Skills:** Agile Methodology, Automation of Tests, Cloud Computing, Software Quality, Continuous Delivery, Continuous Integration, DevOps, Distributed Systems, Failure Mode Effects Analysis, Software Architecture, Systems Development Life Cycle, Secure Hash Algorithm, Software Licensing Audit, Software Engineering, Software Quality Assurance (SQA), 21 CFR Part 820 Quality System Regulation, Data Management - **Published:** October 3, 2026 - **Apply:** https://www.jofdav.com/jobs/59959120-staff-sw-qa-engineer ## About the Role * You have extensive medical device experience demonstrated expertise in FDA 21 CFR Part 820, IEC 62304, ISO 13485, ISO 14971, IEC 82304, EU MDR, and applicable global regulatory requirements. * You have advanced knowledge of software development lifecycle processes and software development methodologies including Agile, Waterfall, DevOps, Continuous Integration, Continuous Delivery (CI/CD), and Test Automation. * You have deep experience with software quality engineering across requirements, architecture, design, development, testing, release, and post-market activities. * You have advanced understanding of software risk management principles, methodologies, and regulatory expectations. * You have demonstrated ability to influence organizational direction and lead cross-functional initiatives without direct authority. * You have strong understanding of software architectures, cloud technologies, distributed systems, cybersecurity principles, and data platforms. * You have experience supporting regulatory inspections and direct interactions with FDA, notified bodies, and external auditors. * You have exceptional written, verbal, and executive-level communication skills. * You have the ability to manage ambiguity, influence senior stakeholders, and drive complex programs to successful completion. * You have demonstrated success mentoring engineers and developing organizational quality capabilities., * Typically requires a Bachelor's Degree in a technical discipline and a minimum of 8-12 years related experience or Master's degree and 5-7 years equivalent industry experience or a PhD and 2-4 years of experience. ## Description Provides technical expertise for software quality assurance activities, including risk management activities following ISO 14971. Supports the development and implementation of scalable quality systems, risk management practices, and software compliance strategies that ensure product safety, effectiveness, and regulatory compliance. Partners with senior R&D engineering, quality, regulatory, clinical, cybersecurity, and business leaders to drive continuous improvements to SDLC, and quality excellence throughout the product lifecycle. Influences organizational quality strategy and serves as a recognized subject matter expert in software quality. Where you come in: * You will serve as a technical leader and subject matter expert for software quality, risk management, software lifecycle compliance activities. * You will lead the effective application, compliance, and continuous improvement of software development and V&V processes, including: Risk Management, Software Design Controls for Class I/II Exempt Applications & Components * You will lead complex software quality initiatives spanning multiple products, programs, and functional organizations. * You will lead risk assessments for software anomalies, cybersecurity vulnerabilities, emerging technologies, and post-market issues. * You will support digital transformation initiatives (ALM, SCM, PLM) to evolve use of electronic systems supporting SDLC as defined per IEC62304. * You will provide technical oversight and direction for software risk management activities, including DFMEA, PFMEA, SHA, and hazard analysis. * You will review and approve critical quality deliverables, including software development lifecycle documentation, risk artifacts, V&V protocols, and design history file content. * You will drive organizational improvements related to software quality systems, development practices, automation, verification, validation, and compliance processes. * You will evaluate emerging regulations, standards, and industry trends and assess impact to existing and future products. * You will collaborate with senior leadership to define quality strategies supporting business objectives and product roadmaps, implementing a right-sized QMS applications based on Software Classification per IEC62304. * You will mentor and provide technical leadership to software quality engineers and cross-functional development teams. * You will influence project, product, and organizational decisions through expert risk-based quality assessments and recommendations. * You will assume and perform other duties as assigned.