Sr Director Quality Assurance

Design Quality Assurance Manager

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.

This is an exciting role in a fast-paced environment directing the development and implementation of the organization's quality assurance policies and programs related to Research and Development across multiple sites. The team will be focused on lean compliance, excellent design transfer into high-volume manufacturing across the globe, to deliver high-reliability products to all the customers and partners that we serve. You will also be collaborating with the Advanced Research Team and next-generation technologies.

Where you come in :

• You will lead all aspects of the Design Assurance and Control process, including Development Quality Engineering, Software Quality Engineering, Product Reliability and Risk Management. Oversee performance and resource allocation across multiple sites.
• You will collaborate closely with R&D and many other cross-functional teams throughout the development lifecycle, including design transfer and commercialization.
• You will leverage customer and consumer feedback to drive continuous improvement initiatives aligned with departmental and corporate strategic goals.
• You will ensure compliance with applicable quality, environmental and safety regulatory, including FDA Quality System Regulation (QSR) as they evolve, and Dexcom's portfolio of products continues to grow.
• You will promote cross-functional understanding and adherence to quality standards and regulatory requirements.
• You will represent the organization during regulatory audits and inquiries, clearly articulating technical details of product design, verification strategies and Design History Files.
• You will manage and track team activities, ensuring milestones are achieved within defined budgets and timelines.

What makes you successful :

You have proven experience in Design Quality Assurance within the medical device industry.

You must have Class II medical devices experience.

You must have a minimum of 12 years of experience in medical device development.

You bring at least 7 years in progressively responsible leadership roles.

You demonstrate an ability to adapt to shifting priorities and manage multiple initiatives.

You possess strong interpersonal, written, and verbal communication skills.

You are self-motivated with a collaborative and proactive approach.

What you'll get :

A front row seat to life changing CGM technology.

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.

Travel Required :

15-25%

Education / Requirements :

Typically requires a Bachelor's degree with 17+ years of industry experience.

13+ years of successful leadership.

An equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Salary : $199,600.00 - $332,600.00