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 we're 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 we've 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. We've already changed millions of lives and we're 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. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've 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.

What Makes You Successful

What you'll get :

Travel Required

Experience And Education

Typically requires a Bachelor's degree with 13+ years of industry experience. Requires a degree in a technical discipline. 5-8 years of previous people management experience.

To all Staffing and Recruiting Agencies : Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes / applications.

Skills Required

Iso 14971, Iso 13485, iec 62304 , Artifactory, Jira, Git, Waterfall Model, Agile Software Development, Bamboo