Staff Quality Compliance Specialist

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. 

Key responsibilities include but are not limited to:

• 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.

What makes you successful:

• You bring familiarity with 21 CFR 806, 21 CFR 820, ISO 13485, MDSAP, EU MDR, and ISO 14971
• You have 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.)
• You may also have Project Management experience and/or ISO 19011 or ISO 13485 Training or Auditor certification

What you’ll get:

• 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.

Travel Required:

• 5-15%

Experience and Education Requirements:

•  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

Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. 

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. Dexcom’s AAP may be viewed upon request by contacting Talent Acquisition at talentacquisition@dexcom.com. 

If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at talentacquisition@dexcom.com. 

Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided:  https://health1.meritain.com/app/public/#/one/insurerCode=MERITAIN_I&brandCode=MERITAINOVER/machine-readable-transparency-in-coverage?reportingEntityType=TPA_19874&lock=true

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.
 

Salary:

$100,700.00 - $167,900.00