Staff QA Engineer

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

Job summary

Dexcom, Inc. is seeking a senior Quality Engineer with a strong background in risk management and process validation to lead high-visibility quality investigations across multiple sites.

You will shape corrective actions, perform root cause analyses, and drive improvements in QMS and product safety for CGM technologies. The role requires technical leadership, excellent communication to senior leadership, and the ability to navigate ambiguity while supporting design transfer and scale-up to

Qualifications

• Bachelor’s degree in a technical discipline with quality engineering experience in regulated manufacturing.
• Experience applying risk-based validation and procedures for IQ/OQ/PQ/PV and TMV.
• Proven ability to distill complex technical information and present to leadership.

Responsibilities

• Lead complex, high-risk quality investigations including CAPAs and HHEs.
• Provide technical leadership in risk management, process validation, and V&V.
• Drive QMS excellence, identify systemic weaknesses, and implement improvements.
• Represent Quality during audits and regulatory inspections with clear written and oral communication.

Skills

Risk management

Root cause analysis

Six Sigma

Statistical analysis

FMEAs

Quality leadership

Documentation

Cross-functional collaboration

Education

Chemical Engineering or similar degree

Tools

JMP

Excel

Job description

The CompanyDexcom 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 in cross-site and cross-functional alignment for the future of Dexcom and for the future of our customers’ health. You will support Dexcom in bringing state-of-the-art innovative technology to patients and will help to define, support, and improve the processes that get us there. A positive and team-oriented approach is important as you navigate shifting priorities, technical ambiguity, and complex cross-functional decisions.Where you come in:You lead complex, high-risk quality investigations, including root cause analysis, CAPAs, NCMRs/MRB, Health Hazard Evaluations (HHEs), and other product and process risk assessments, driving appropriate disposition and sustainable corrective actions.You provide technical leadership and guidance in quality engineering, including risk management, Six Sigma, process capability, statistical analysis, sampling strategies, and risk-based problem solving.You drive Quality Management System excellence by identifying systemic weaknesses and leading sustainable improvements to procedures, process controls, validation frameworks, FMEAs, and other quality processes across functions or sites.You define and provide technical leadership for risk-based validation and qualification strategies, including equipment and process qualification, Test Method Validation (TMV), measurement system analysis, and software V&V, ensuring compliance and product safety throughout the product lifecycle.You serve as a quality engineering technical lead across complex cross-functional initiatives, communicating technical and compliance issues clearly through written documentation, oral communication, and presentations to technical teams and senior leadership, while driving decisions and alignment across functions and sites.You provide risk-based quality leadership for design transfer, commercialization, and significant product or process changes, influencing technical decisions and establishing robust controls as products and processes scale to high-volume manufacturing.You represent Quality during internal audits and external regulatory inspections, providing subject matter expertise, leading responses to complex technical issues, and helping shape organizational quality and compliance strategy.What makes you successful:Your Chemical Engineering or similar degree from an accredited college or university, with substantial quality engineering experience in regulated manufacturing environments.Your advanced application of quality engineering principles, including risk management, root cause analysis, statistical analysis, process capability, sampling plans, measurement system analysis, and data-driven decision-making using tools such as JMP and Excel.Your demonstrated experience developing and evaluating risk-based validation strategies, including IQ/OQ/PQ/PV, Test Method Validation (TMV), measurement system analysis/Gage R&R, and software V&V.Your experience applying risk-based quality engineering to design transfer, commercialization, manufacturing issues, and process changes, with the ability to move between detailed technical problem solving and broader quality strategy.Your advanced written, oral, and presentation skills, with the ability to distill complex technical information, communicate risk and recommendations clearly, influence without direct authority, and present confidently to technical teams, cross-functional stakeholders, and senior leadership.Your demonstrated ability to operate independently with minimal direction, navigate ambiguity, establish technical direction, and lead multiple high-priority quality initiatives across functions or sites.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:0-5%Experience and Education Requirements:Typically requires a Bachelor’s degree in a technical discipline, and a minimum of 8 12 years related experience or Master’s degree and 5-7 years equivalent industry experience or a PhD and 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] 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], 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=trueTo 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.AI in Hiring Notice: We may use AI supported tools to help make our hiring process more efficient, consistent, and accessible for candidates around the world. All hiring decisions are made by people.Salary:$111,100.00 - $185,100.00#DexcomUS