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Dexcom Deutschland GmbH · 22 hours ago

Staff Quality Compliance Specialist

San Diego, CA

Full-time

Hybrid

Lead/Staff

$101K/yr - $168K/yr

8+ years exp

Dexcom Corporation is a pioneer and global leader in continuous glucose monitoring (CGM). The Staff Quality Compliance Specialist will lead and collaborate on audits, field action activities, and continuous improvement projects to ensure compliance and safety in health technology products.

Medical Device

Responsibilities

You will 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

You will lead or collaborate on Field Action activities, as designated, including Strategy, Communications, Reporting, and Evidence Gathering

You will compose or collaborate on communications with regulatory bodies

You will identify and drive quality compliance and cross-functional continuous improvement initiatives

You will act as the subject matter expert on the above areas during Internal and/or External Audits

Qualification

21 CFR 80621 CFR 820ISO 13485MDSAPEU MDRISO 14971Compliance experienceProject ManagementISO 19011Auditor certification

Required

Typically requires a Bachelor's degree and a minimum of 8-12 years of related experience

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.)