Sr QA Engineer

Regulatory Toolkit; San Diego (CA); On-site; USD 87,000 - 145,000; Full time

Benefits offered by this job

Comprehensive benefits

Global growth opportunities

Career development programs

Industry-leading company

Job summary

Dexcom Corporation is seeking a seasoned Quality Engineer to lead complex quality investigations and drive compliance across the product lifecycle. You will provide technical leadership in quality engineering, continue improvement, validation strategies, and software V&V expertise.

You will partner with R&D, Regulatory Affairs, Manufacturing and global teams to ensure robust quality solutions. Join a fast-paced, cross‑functional team focused on CGM technology and patient outcomes.

Qualifications

• Bachelor’s degree in a technical discipline with 5–8 years related experience
• Master’s degree with 2–5 years, or PhD with 0–2 years experience

Responsibilities

• Lead complex quality investigations and root cause analysis with CAPAs and MRBs
• Provide technical leadership in quality engineering and continuous improvement
• Drive Quality Management System excellence through procedures and validation frameworks
• Own validation/qualification strategies for equipment, processes, test methods and software V&V
• Serve as quality engineering lead on cross‑functional projects with R&D, Regulatory, Manufacturing
• Guide design transfer and commercialization to scale from development to high-volume manufacturing
• Mitigate risk by influencing design decisions and implementing robust controls
• Identify and close compliance gaps across sites and functions
• Communicate technical/compliance topics effectively to stakeholders
• Represent Quality during internal audits and regulatory inspections

Skills

Quality engineering

Risk management

Root cause analysis

Six Sigma

Data analysis

Education

Bachelor’s degree in technical discipline

Master’s degree

Tools

JMP

Excel

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 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 attitude is important while working in a fast-paced environment and dealing with shifting priorities.

Where you come in:

• You lead complex quality investigations by driving root cause analysis, CAPAs, NCMRs (including MRB/disposition decision-making), and systemic corrective actions that improve product quality and compliance.
• You provide technical leadership in quality engineering and continuous improvement methodologies, including Six Sigma, Lean Manufacturing, process capability analysis (Cpk/Ppk), Gage R&R, sampling plans, and risk-based problem solving.
• You drive Quality Management System excellence through continuous improvement of procedures, process controls, validation frameworks, FMEAs, and quality processes.
• You own validation and qualification strategies for equipment, processes, test methods, and software V&V, ensuring compliance and product safety throughout the product lifecycle.
• You serve as the quality engineering lead on cross-functional projects, partnering closely with R&D, Regulatory Affairs, Manufacturing, Operations, Engineering, and global teams to achieve successful business outcomes.
• You guide design transfer and commercialization efforts, ensuring new products and processes are successfully scaled from development through high-volume manufacturing.
• You assess and mitigate risk by influencing design decisions, evaluating process changes, and implementing robust controls that ensure reliable product performance and regulatory compliance.
• You identify and close compliance gaps by proactively assessing quality system weaknesses and leading sustainable corrective and preventive actions across sites and functions.
• You communicate complex technical and compliance topics effectively through effective written and verbal communication, influencing stakeholders and driving alignment across cross-functional and international teams.
• You represent Quality during internal audits and external regulatory inspections, providing subject matter expertise and helping shape organizational quality and compliance strategy.

What makes you successful:

• Your Chemical Engineering or similar degree from accredited College/University with experience supporting regulated manufacturing environments.
• Your advanced quality engineering knowledge, including risk management, root cause analysis, Six Sigma, process capability analysis (Cpk/Ppk), statistical analysis, sampling plans, AQL, and data-driven decision-making.
• Your demonstrated experience developing and executing validation strategies, including IQ/OQ/PQ/PV, test method validation, software V&V, and process validation activities.
• Your proficiency in design transfer and commercialization, applying risk-based decision making to successfully transition new products and processes from development into high-volume manufacturing.
• Your strong technical aptitude with a hands-on approach, partnering directly with manufacturing teams to assess risk, troubleshoot issues, and drive sustainable process improvements.
• Your proficiency with data analysis tools such as JMP and Excel, leveraging data to generate actionable insights that support business and quality objectives.
• Your ability to communicate complex technical and compliance topics effectively across all organizational levels, influencing stakeholders and presenting confidently to senior leadership.
• Your cross-functional leadership, building alignment across Engineering, Operations, R&D, Regulatory Affairs, and global teams to deliver comprehensive quality solutions.
• Your experience with chemistry in manufacturing and associated risks (polymers and analytical experience preferred).
• Your strong ownership, integrity, and organizational agility, successfully managing multiple high-priority initiatives while driving strategic quality and compliance improvements in a fast-paced environment.

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 in a technical discipline, and a minimum of 5-8 years related experience or Master’s degree and 2-5 years equivalent industry experience or a PhD and 0-2 years 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].

Salary: $87,000.00 - $145,000.00

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