Sr Manager Quality Assurance

The Company

Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And were just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what weve started: Improving human health.

We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. Weve already changed millions of lives and were ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. Well get there by constantly reinventing unique biosensing-technology experiences. Though weve come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.

Meet The Team

This functional department provides technical support and guidance to Software teams to ensure conformance to software development process and other applicable safety and quality system regulation and standards (e.g. IEC 62304, ISO 13485, ISO 14971). We are responsible for various aspects of Software Design Assurance with focus on product improvement, new product development and defect prevention. We interface with different cross functional groups (Software Engineering, Software Test, Regulatory Affairs, Marketing, Project managers, Systems Engineering and others). This team has a great team culture supporting each other in a fast-paced environment and dealing with shifting priorities with a positive attitude. This is not a test role

The Senior Manager of Software Quality Engineering is responsible for implementing and maintaining a software design quality system that meets internal business objectives and global regulatory requirements. Leads cross functional alignment initiatives to implement process improvements to support rapid growth. Maintains and improves QMS to ensure compliance to regulatory requirements while keeping procedures efficient to support business needs. This position is responsible for all aspects of Software product quality and performance along with ownership of risk management activities throughout a Software product’s lifecycle from new product development through on-market product performance. Provides guidance on IEC 62304, 21 CFR 820 and ISO 13485 for Software in Medical devices.

Where You Come In

• You will be responsible for maintaining the design control system for software components, including but not limited to design verification and validation, design history file, and risk management throughout the software’s lifecycle.
• You will supervise teams in terms of costs, methods, and staffing.
• You will be a leader driving changes and creating a culture of continuous improvements in the software world to deliver faster software solutions with the highest performance.
• You will be a strong tactical decision-maker, handling unforeseen issues related to software’s compliance with regulations.
• You will interact and communicate with senior leadership regarding risks, mitigation plans, and status updates on business objectives.
• You will ensure teams are audit ready.
• You will understand domestic and international Quality System requirements and provide Software Quality guidance to cross-functional departments.
• You will participate and provide guidance on post-market risk management activities like health hazard assessments and CAPAs.
• You will direct device quality activities across different projects and business units.
• You will maintain cooperative relationships with cross-functional departments, including but not limited to R&D, Regulatory, Marketing, and Clinical.
  
  

• You have medical device experience in compliance with the requirements of FDA 21 CFR Part 820, IEC 62304, ISO 13485, and ISO 14971.
• You have knowledge and experience with SDLC processes along with software development methodologies such as Agile Software Development, Waterfall Model, etc.
• Your management and mentorship skills and experience are essential.
• You have software quality or engineering experience in requirements analysis, design/development, product integration, and testing.
• Your ability to communicate and present to all levels of management is crucial.
• You have the ability to understand complex tasks and goals, and you drive projects to completion with limited supervision.
• Your ability to deal with ambiguity and uncertainty, and your willingness to try new and challenging things, are valuable.
• You have a proven ability to work hands-on in a fast-paced environment.
• Your eagerness to share or try out new ideas, perspectives, or solutions is appreciated.
• You have the ability to establish departmental objectives and goals.
• Nice to have: ASQ Certified Software Quality Engineer (CSQE)
• Nice to have: Knowledge of CI/CD and tools widely used by software teams like JIRA, Bamboo, JAMA, DNG, Git, Artifactory, etc.
• Nice to have: Experience in directly managing the coordination of activities within a function/department with responsibility for results.
• Nice to have: Experience in managing 2 or more sections of the department. May be responsible for a functional area or contracted/outsourced employees or matrixed reports without having direct reports within the organization.
• Nice to have: Experience in people management responsibilities including hiring/terminations, performance reviews, career development coaching, and compensation decisions.
  
  

• A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community.
• 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.
• An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.
  
  

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