Staff Quality Compliance Specialist

Dexcom • San Diego, CA

1d

About The Position

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: The Quality Compliance Team leads vital compliance functions to ensure Dexcom maintains good standing with notified bodies and regulators, while positively impacting processes to ensure patients receive safe and effective products to empower them to take control of their health. Where you come in: The Staff Quality Compliance Specialist leads and/or collaborates to coordinate designated Audits, leads and/or supports Field Action Activities, and leads or collaborates on additional continuous improvement projects, such as the creation and maintenance of a Global Compliance Matrix.

Requirements

• Familiarity with 21 CFR 806, 21 CFR 820, ISO 13485, MDSAP, EU MDR, and ISO 14971
• Compliance experience (e.g., worldwide quality and compliance regulations including Canada, Europe, etc.) and experience coordinating with foreign agents (Authorized Representatives, Market Authorization Holders, etc.)
• Typically requires a Bachelor's degree and a minimum of 8-12 years of related experience.
• At this level a graduate degree may be desirable with 4 years of related experience

Nice To Haves

• Project Management experience and/or ISO 19011 or ISO 13485 Training or Auditor certification

Responsibilities

• Coordinate Audits including scheduling, audit logistics, audit execution, and follow-up of post-audit activities. Also includes collaboration to support organizational preparedness for audits, including readiness for unannounced inspections.
• Lead or collaborate on Field Action activities, as designated, including Strategy, Communications, Reporting, and Evidence Gathering.
• Compose or collaborate on communications with regulatory bodies.
• Identify and drive quality compliance and cross-functional continuous improvement initiatives.
• Act as the subject matter expert on the above areas during Internal and/or External Audits.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees