Senior Manager of Quality Compliance CAPA

DexCom

Job Location:

San Diego, CA - USA

Monthly Salary: $ 141800 - 236400

Posted on: 5 days ago

Vacancies: 1 Vacancy

Job Summary

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 were 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 weve 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. Weve already changed millions of lives and were 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. Well get there by constantly reinventing unique biosensing-technology experiences. Though weve 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 Senior Manager Quality Compliance CAPA Program is a strategic quality leadership role responsible for the design execution and continuous improvement of Dexcoms global Corrective and Preventive Action (CAPA) program.

This role owns the CAPA quality system end-to-end and leads a team of CAPA Coaches who support cross-functional partners in driving timely effective and compliant issue resolution.

The ideal candidate is a seasoned quality systems leader with deep expertise in CAPA regulations strong leadership skills and a proven ability to influence at all levels of the organization. This role is critical to maintaining regulatory compliance inspection readiness and a culture of sustainable continuous improvement.

Where you come in:

CAPA Program Leadership

Own and continuously improve Dexcoms global CAPA process to ensure compliance with QMSR/ISO 13485/MDSAP and global regulatory expectations.
Serve as the final quality authority for CAPA-related decisions including adequacy of root cause correction vs. corrective action and effectiveness verification.

Team Leadership & Development

Lead coach and develop a team of Sr. CAPA Engineers ensuring consistent application of CAPA principles and high-quality outcomes.
Build team capability in root cause analysis risk management investigation techniques and effectiveness checks.

Cross-Functional Influence

Partner with Manufacturing R&D Operations Post-Market Surveillance Regulatory Affairs and Supply Chain to ensure CAPAs are effectively driven to closure.
Act as a trusted advisor to functional leaders on CAPA strategy systemic issue resolution and compliance risk.

Inspection & Audit Readiness

Represent the CAPA program during FDA inspections notified body audits and internal audits.
Ensure CAPA-related responses to regulatory observations (e.g. 483s audit findings) are robust timely and sustainable.

Metrics Reporting & Continuous Improvement

Define and monitor CAPA KPIs (e.g. cycle time aging effectiveness recurrence).
Use data analytics and trend analysis to identify systemic quality issues and improvement opportunities.

What makes you successful:

Experience scaling or transforming a CAPA program in a fast-growing organization.
Strong background in risk management (ISO 14971) and linkage between CAPA and risk.
Experience with electronic QMS (eQMS) platforms.
ASQ certification (CQA CQE) or equivalent.
Strategic thinker with strong execution discipline
Influential leader with the ability to drive alignment without authority
Excellent written and verbal communication skills
High judgment and comfort making decisions in complex ambiguous situations

What youll 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:

0-5%

Education and Experience:

Typically requires a Bachelorsdegree with 13 years ofindustry experience
5-8 years of previous peoplemanagement experience

Flex Workplace: Your primary location will be a home office. You will not have an assigned workstation and will work with your manager to determine office visit needs. You must live within commuting distance of your assigned Dexcom site (typically 75 miles/120km).

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. Dexcoms AAP may be viewed upon request by contacting Talent Acquisition at

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

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: 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:

$141800.00 - $236400.00

Required Experience:

Senior Manager

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 ...