Senior Manager Software QA Engineering

DexCom • San Diego, CA

1d • Remote

About The Position

The Senior Manager, Software Quality Engineering is responsible for leading all aspects of software quality assurance, including managing and mentoring the QA team. This role works closely with cross-functional teams to ensure that the development, testing, and release of product software and supporting infrastructure comply with U.S. and international regulatory standards. Additionally, this position oversees the partnerships component of the Quality Management System (QMS) and leads a dedicated team for that function.

Requirements

• At least 7 years in software QA or development for medical devices, including 5 years leading high-performing teams
• Thrive in Agile environments with strong knowledge of automated testing and regulatory standards like IEC 62304 and FDA guidance
• Leads with confidence, manage teams, processes, and compliance in a fast-paced, regulated setting
• Apply your deep understanding of Quality, Regulatory, and R&D systems within medical devices or other highly regulated industries
• Communicate with impact, strong leadership and stakeholder management skills are essential
• Drive change by analyzing business processes, designing improvements, and empowering users through training
• Craft clear, compelling documentation and presentations that make complex strategies and technical concepts easy to understand
• Be a positive, results-driven team player who brings logic and collaboration to every challenge
• Embrace innovation- Ability to learn quickly, adapt to new technologies , and juggle multiple projects with ease
• Work independently while meeting deadlines and delivering exceptional results
• Bachelor’s degree, preferably in an Engineering or STEM discipline, with 13+ years of industry experience
• 5-8 years of previous people management experience

Nice To Haves

• Proficiency in modern programming languages .
• Experience with cloud platforms (Azure, AWS, Google Cloud) and big data tools.
• Familiarity with mobile and wearable software development.
• Expertise in FDA regulations (21 CFR Part 11 & 820) and cybersecurity guidance.
• BI/AI Platform Experience is a plus
• Experience with Mobile application development

Responsibilities

• Align technology solutions with business objectives , ensure regulatory compliance, and provide mentorship to the Software QA and partnerships teams.
• Manage the software development lifecycle (SDLC) and define key performance metrics for reporting to senior leadership.
• Ensure compliance with IEC 62304, FDA software validation principles, and cybersecurity guidance throughout the development process.
• Prepare and present quality findings to executive management and R&D leadership; monitor and resolve ongoing issues.
• Collaborate with R&D, Operations, CyberSecurity , and V&V teams to maintain efficient, compliant development and testing processes.
• Lead risk assessments, health Hazard assessments and guide mitigation strategies. Also support CAPAs as applicable.
• Maintain validated states, review change control documentation, and present validation records during audits. Promote best practices in system design and development.
• Participate in design reviews, assist with defining software inputs, and verify outputs against requirements.
• Identify compliance gaps, evaluate new regulations, and update procedures in collaboration with relevant departments. Support organization-wide remediation efforts related to regulatory findings.
• Perform additional responsibilities as assigned.

Benefits

• A full and comprehensive benefits program.
• Growth opportunities on a global scale.
• Access to career development through in-house learning programs and/or qualified tuition reimbursement.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager