Sr Director, QMS
Job Location:
San Diego, CA - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
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 Quality Management Systems (QMS) team at Dexcom plays a critical role in ensuring the integrity compliance and scalability of our global quality framework. As a strategic function within Global Quality the teamis responsible formaintaininga robust compliant and continuously improving QMS that supports product development manufacturing and post-market activities across all regions.
We partner cross-functionally with R&D Regulatory Affairs Manufacturing Supply Chain and Commercial teams to embed quality into every stage of the product lifecycle. Our mission is to enable innovation whilemaintainingthe highest standards of safety compliance and patient impact. As Dexcom continues to grow globally the QMS team ensures our processes evolve to meet increasingly complex regulatory requirements while staying efficient and scalable.
Where you come in:
As the Sr. Director of Quality Management Systems you will provide strategic leadership and oversight for Dexcoms global QMS ensuring it meets all applicable regulatory requirements (FDA ISO 13485 MDR and other international standards) while supporting business growth and innovation.
You will:
Own and evolve the global QMS strategy ensuring alignment with corporateobjectivesand regulatory expectations
Lead the design implementation and/orcontinuous improvement of key QMS processes including document control CAPAmetrics and analyticspartnershipmanagementaudit managementamongothers.
Own thecorporateCAPA programensuring world class execution andperformance.
Drive harmonization and standardization of quality processes across global sites and regions
EstablishaQualityIntelligence program that focuses onrisks and developments across the medical device industry.
OwnProjectManagementfor the Qualityorganization focusing on continuous improvement opportunities.
Ensure inspection readiness at all timesandassistwithenterprise-level responses to regulatory inspections and audits
Partner closely with Regulatory Affairs to interpret evolving global regulations and proactively integrate requirements into the QMS
Build develop and lead a high-performingglobalQMS team
Champion a culture of quality compliance and continuous improvement across the organization
Leverage digital tools and data analytics to modernize and scale the QMS improving efficiency and visibility
Provide executive-level reporting on QMS performance risks and improvement initiatives
What makes you successful:
You are a strategic forward-thinking quality leader who can balance compliance with agility in a fast-pacedinnovation-driven environment.
Leadership & Influence
Proven ability to lead and scale global teams driving alignment across functions and geographies
Strong executive presence with the ability to influence senior leadership and cross-functional stakeholders
Quality & Regulatory Expertise
Deep knowledge of global QMS requirements including FDA 21 CFR Part 820 ISO 13485 EU MDR and other international standards
Demonstrated success leading regulatory inspections and audits with positive outcomes
Experience building or transforming QMS frameworks inacomplex global organization
Operational Excellence
Track recordof implementing scalable efficient quality processes that support rapid business growth
Strong systems mindset with experience driving digital transformation within QMS platforms (e.g.eQMSsystems)
Data-driven decision-maker who uses metrics to drive continuous improvement
Strategic Mindset
Ability toanticipateregulatory trendsandcorporate needsand proactively adapt systems and processes
Strong business acumen with an understanding of howQuality enables innovation and market success
Collaboration & Communication
Excellent cross-functional collaboration skills with the ability to translate complex regulatory requirements into practical business-friendly solutions
Clear and compelling communicator capable of engaging audiences from frontline teams to executive leadership
Whatyoullget:
A front row seat tolife changingCGM technology.Learn about our brave #dexcomwarriors community.
Afull andcomprehensive benefitsprogram.
Growth opportunities on a global scale.
Access tocareer development through in-house learning programs and/orqualifiedtuition reimbursement.
Anexcitingandinnovativeindustry-leading organizationcommitted to our employeescustomers and the communities we serve.
Travel Required:
15-25%
Experience and Education Requirements:
Typically requires a Bachelorsdegree with 17 years of industryexperience
13 years of years of successfulleadership experience in relevant
industry
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:
$209600.00 - $349300.00Required Experience:
Exec
About Company
Dexcom Continuous Glucose Monitoring is simplifying diabetes management with a small device, accurate real-time glucose readings, and proven results. No fingersticks or scanning.†
