Director SW Quality - Consumer Applications

The Director of Software Quality Engineering - Consumer Applications is responsible for all aspects of Software Quality Engineering related to Consumer Applications and Data Platform Solutions including managing and mentoring Quality Engineering staff responsible for Consumer Applications ecosystem. This role partners closely and collaboratively with R&D, Regulatory and Medical Affairs to drive the development, test and release of Product Software Consumer and Digital Health Apps, and supporting data platforms infrastructure while ensuring the development process is compliant with all regulatory and quality system requirements.

* Manages the Software Quality Assurance Consumer Applications & Data Platform Solution Team(s). Defines priorities and delegates responsibilities.

* Leverage customer and consumer feedback to drive continuous improvement initiatives aligned with departmental and corporate strategic goals.

* Promote cross-functional understanding and adherence to quality standards and regulatory requirements.

* Responsible for establishing and reporting on key software development metrics.

* Provides coaching and guidance on defining world class project plans, requirements, design, and test cases.

* Create a lightweight SDLC for Class I/II Exempt Applications / Component based on risk and software classifications as defined in IEC 62304

* Deep understanding of software requirements and best practices toward:

* IEC 62304 compliance, Software as a Medical Device (SaMD) and Software in a medical device

* Product IOT environment, Digital Health and Clinical Decision Support Tools

* FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

* FDA Guidance for Content of Premarket Submissions for Management of Cybersecurity in Medical Devices

* FDA Guidance for Post-market Management of Cybersecurity in Medical Devices

* Electronic ALM Systems - Requirements, Risk, Test, Defect and Configuartion Management

* Work with R&D to ensure development and test processes comply with the latest regulations and identify potential compliance gaps; work with the departments to discuss how to apply best practices to meet regulations.

* With assistance and buy in from departments, update relevant procedures.

* Lead risk management activities to drive collaborative discussions on appropriate mitigation strategies.

* Provide leadership and expertise in the Design/ Phase Review process to ensure compliance to PDP.

* Coordinates, manages and tracks the team's efforts, ensuring milestones are met within defined budgets and schedules.

* Expertise or strong working knowledge of Food and Drug Administration 21 CFR PART 820, Quality System Regulation

* Expertise or strong working knowledge of Food and Drug Administration 21 CFR PART 11, Electronic Records; Electronic Signatures.

* Expertise or strong working knowledge of SDLC GxP Tools - ALM for Software, Configuration Management and Defect Management

* Typically requires a Bachelor's degree with 15+ years of industry experience

* 9+ years of successful management experience in relevant industry

Remote Workplace: Your location will be a home office; you are not required to live within commuting distance of your assigned Dexcom site (typically 75 miles/120km). If you reside within commuting distance of a Dexcom site (typically 75 miles/120km) a hybrid working environment may be available. Ask about our Flex workplace option.

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