Staff QA Engineer

Regulatory Toolkit; San Diego (CA); On-site; USD 111,000 - 185,000; Full time

Benefits offered by this job

Comprehensive benefits package

Global growth opportunities

Career development programs

Access to innovative CGM technology

Job summary

Dexcom seeks a senior quality engineering leader to drive regulatory compliance and manufacturing quality in high-volume automation. You will shape validation strategies, oversee design transfer, and guide complex investigations across global sites.

You will mentor teams, lead CAPA programs, and strengthen the Quality Management System in support of Dexcom’s CGM innovations and patient impact.

Qualifications

• Bachelor’s degree in a technical discipline with 8–12 years of related experience, or Master’s with 5–7 years, or PhD with 2–4 years.
• Experience applying FDA/ISO requirements to design transfer and process validation.
• Demonstrated leadership in cross-functional teams and audits.

Responsibilities

• Lead regulatory compliance and quality engineering for high-volume manufacturing.
• Architect validation strategies and oversee design transfer to manufacturing sites.
• Steer investigations, CAPA, MRB decisions, and systemic improvements.
• Coordinate cross-site alignment on complex quality and compliance topics.

Skills

FDA 21 CFR 820

ISO 13485

Quality management

Root-cause analysis

Six Sigma

Data analysis (Excel/JMP)

Cross-functional leadership

Regulatory inspections

Design transfer

Education

Bachelor's degree in a technical discipline

Master's degree

PhD

Tools

Excel

JMP

Job description

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:

Join us in empowering people to take control of their health! You will join a collaborative team at the heart of Dexcom’s products. Our quality engineering team plays a crucial role inglobalcross-site and cross-functional alignment for the future of Dexcom and for the future of our customers’ health. You will support Dexcom in bringingstate-of-the-artinnovative technology to patients and will help define, support, and improve the processes that get us there.

Where you come in:

• You serve as a technical leaderonnew high‑volume manufacturing automation equipment development teams. You interpret and guide the application of regulatory requirements, shape equipment and process design requirements, influence risk‑based design decisions, and architect validation strategies across programs.
• You drive Design Control andspecificallydesign transferstrategyfor new products, ensuring scalable, high‑volume manufacturing readiness across global sites. You partner with Operations tooptimizethe transition from pilot builds through commercial automation deployment.
• You provide manufacturing quality engineering leadership for the development,process validation, and commercialization of new processes. You lead complex investigations, guide MRB decision‑making, and drive systemic improvements across equipment and process designs.
• You lead alignment across multi‑level, cross‑functional, and international teams on complex technical and compliance topics, setting direction and resolving ambiguities to ensure consistent implementation across sites.
• Youprovideexpert‑level guidance in strengthening and governing the Quality Management System, including FMEAmethodology,processvalidation architecture, CAPA strategy, process controls, and nonconformance management.
• You proactivelyidentifysystemic compliance or procedural gaps across programs or sites and lead the teams that develop and implement corrective and preventive actions with cross‑functional buy‑in.
• Yourepresentthe organization during internal audits and external regulatory inspections, providing subject‑matterexpertiseand influencing quality strategy and responses.
• You mentor engineers and cross‑functional partners, elevating quality engineeringproficiencyand ensuring consistent application of best practices across teams.

What makes you successful:

• You have deep, hands‑on experience with FDA 21 CFR 820, ISO 13485, and related Quality Management System requirements, and you can interpret and apply them at a system and program level.
• Youare proficientat reviewing and interpreting complex technical documentation, engineering drawings, and specifications, and you can guide others in doing the same.
• You bringadvancedlevel skills in root cause analysis, Six Sigma methodologies, structured problem solving, test method validation, software validation, process validation, process capability (e.g.,Cpk/Ppk), lean manufacturing, sampling plans, and statistical analysis.
• You have strongproficiencyin data analysis tools such as Excel and JMP and can guide teams in developing robust data‑driven decisions.
• You communicate with clarity and influence across all levels of the organization, ensuring alignment with engineering, operations, leadership, and global partners.
• You formulate and drive implementation of comprehensive, cross‑functional quality solutions, gaining alignment across stakeholders and global sites.
• You independently organize, prioritize, and lead strategic initiatives while serving as a key contributor on cross‑functional teams.
• You consistentlydemonstrateinitiative, ownership, and integrity in driving high‑impact quality and compliance improvements.
• You thrive in a dynamic environment and support the broader quality andoperationsorganizations as needed.

Whatyou’llget:

• 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.
• Anexcitingandinnovative,industry-leading organizationcommitted to our employees,customers, and the communities we serve.

Travel Required:

• 5-15%

Experience and Education Requirements:

• Typically requires a Bachelor’s degreein a technical discipline, and a minimumof 8-12 years related experience orMaster’s degree and 5-7 yearsequivalent industry experience or a PhDand 2-4 years of 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 [e-mail].

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 [e-mail].

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.

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Salary:

$111,100.00 - $185,100.00

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