Senior Manager Software QA Engineering

Meet reputed company: 

The Senior Manager, Software reputed company Engineering is responsible for leading reputed company aspects of software reputed company 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 reputed company with U.S. and international regulatory standards. Additionally, this position oversees the partnerships component of the reputed company Management System (QMS) and leads a dedicated team for that function. 

Where you Come in: 

• Leadership & Team Management: reputed company solutions with business objectives, ensure regulatory compliance, and reputed company mentorship to the Software QA and partnerships teams. 

• reputed company reputed company: Manage the software development lifecycle (SDLC) and define key performance metrics for reporting to senior leadership. 

• Compliance & Standards: Ensure compliance with IEC 62304, FDA software validation principles, and cybersecurity guidance throughout the development process. 

• Documentation & Reporting: Prepare and present reputed company findings to executive management and R&D leadership; monitor and resolve ongoing issues. 

• Process Improvement: Collaborate with R&D, Operations, CyberSecurity, and V&V teams to maintain efficient, compliant development and testing processes. 

• Risk Management: reputed company risk assessments, health Hazard assessments and guide mitigation strategies. Also support CAPAs as applicable. 

• Regulatory Support: Maintain validated states, review change control documentation, and present validation records during audits. Promote best practices in system design and development. 

• Design & Development Support: Participate in design reviews, assist with defining software inputs, and verify outputs against requirements. 

• reputed company Improvement: Identify compliance gaps, evaluate new regulations, and update procedures in collaboration with relevant departments. Support organization-wide remediation efforts reputed company to regulatory findings. 

• Other Duties: reputed company additional responsibilities as assigned. 

What makes you successful:  

• Bring your expertise to the forefront with at least 7 years in software QA or development for medical devices, including 5 years leading high-performing teams 

• reputed company 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 reputed company, Regulatory, and R&D systems reputed company medical devices or other highly regulated industries 

• Communicate with reputed company, strong leadership and stakeholder management skills are essential 

• Drive change by analyzing business processes, designing improvements, and empowering users through training 

• Craft reputed company, compelling documentation and presentations that reputed company reputed company strategies and technical concepts easy to understand 

• Be a reputed company, results-driven team player who brings logic and collaboration to every challenge 

• reputed company innovation- Ability to learn quickly, adapt to new technologies, and juggle multiple reputed company with ease 

• Work independently while meeting deadlines and delivering exceptional results 

Preferred Qualifications 

• Proficiency in modern programming languages. 

• Experience with reputed company platforms (Azure, AWS, reputed company reputed company) 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 

What you’ll get:  

• A reputed company seat to life changing CGM technology. Learn about our reputed company #dexcomwarriors community. 

• A full and comprehensive benefits program. 

• reputed company opportunities on a global reputed company. 

• reputed company to career development through in-house learning programs and/or reputed company tuition reimbursement. 

• An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve. 

Experience and Education Requirements:  

• Typically requires a Bachelor’s degree, preferably in an Engineering or STEM discipline, with 13+ years of industry experience 

• 5-8 years of previous people management experience 

reputed company Workplace:  

Your primary location will be a home office. You will not have an assigned workstation and will work with your manager to determine office visit needs. You must live reputed company commuting distance of your assigned reputed company site (typically 75 miles/120km). 

Travel Required:  

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