Staff Quality Compliance Specialist jobs in United States
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Dexcom · 1 day ago

Staff Quality Compliance Specialist

Dexcom Corporation is a pioneer and global leader in continuous glucose monitoring (CGM). The Staff Quality Compliance Specialist will lead and coordinate audits, support field action activities, and drive quality compliance initiatives to ensure patient safety and effective product delivery.

DiabetesHealth DiagnosticsMedical DeviceSensor
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H1B Sponsor Likelynote

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 ManagementAuditor certificationContinuous improvementCommunication skillsCollaboration skills

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.)
Ability to coordinate Audits including scheduling, audit logistics, audit execution, and follow-up of post-audit activities
Ability to lead or collaborate on Field Action activities, including Strategy, Communications, Reporting, and Evidence Gathering
Ability to compose or collaborate on communications with regulatory bodies
Ability to 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

Preferred

Project Management experience and/or ISO 19011 or ISO 13485 Training or Auditor certification
A graduate degree may be desirable with 4 years of related experience

Benefits

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.

Company

Dexcom develops, manufactures, and distributes continuous glucose monitoring systems for diabetes management.

H1B Sponsorship

Dexcom has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (54)
2024 (41)
2023 (67)
2022 (75)
2021 (49)
2020 (36)

Funding

Current Stage
Public Company
Total Funding
$2.16B
Key Investors
RWI Group
2023-05-02Post Ipo Debt· $1B
2020-05-12Post Ipo Debt
2018-11-01Post Ipo Equity· $750M

Leadership Team

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Jacob Leach
Chief Operating Officer
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Matt Dolan
Executive Vice President, Strategy, Corporate Development & Dexcom Labs
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Company data provided by crunchbase