Staff QA Engineer

Dexcom • San Diego, CA

5d

About The Position

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 global 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 define, support, and improve the processes that get us there. Where you come in: You serve as a technical leader on new 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 and specifically design transfer strategy for new products, ensuring scalable, high‑volume manufacturing readiness across global sites. You partner with Operations to optimize the 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. You provide expert‑level guidance in strengthening and governing the Quality Management System, including FMEA methodology, process validation architecture, CAPA strategy, process controls, and nonconformance management. You proactively identify systemic 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. You represent the organization during internal audits and external regulatory inspections, providing subject‑matter expertise and influencing quality strategy and responses. You mentor engineers and cross‑functional partners, elevating quality engineering proficiency and ensuring consistent application of best practices across teams. 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. Since 1999, Dexcom has simplified and revolutionized diabetes management, positively impacting millions worldwide. At Dexcom, we're more than just a medical device company; we're a collective of visionary thinkers, trailblazers, and problem solvers. Our mission transcends the ordinary. We aim to revolutionize healthcare, one groundbreaking technology at a time.

Requirements

• 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.
• You are proficient at reviewing and interpreting complex technical documentation, engineering drawings, and specifications, and you can guide others in doing the same.
• You bring advanced level 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 strong proficiency in 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 consistently demonstrate initiative, ownership, and integrity in driving high‑impact quality and compliance improvements.
• You thrive in a dynamic environment and support the broader quality and operations organizations as needed.
• 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.

Responsibilities

• Serve as a technical leader on new high‑volume manufacturing automation equipment development teams.
• 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.
• Drive Design Control and specifically design transfer strategy for new products, ensuring scalable, high‑volume manufacturing readiness across global sites.
• Partner with Operations to optimize the transition from pilot builds through commercial automation deployment.
• Provide manufacturing quality engineering leadership for the development, process validation, and commercialization of new processes.
• Lead complex investigations, guide MRB decision‑making, and drive systemic improvements across equipment and process designs.
• 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.
• Provide expert‑level guidance in strengthening and governing the Quality Management System, including FMEA methodology, process validation architecture, CAPA strategy, process controls, and nonconformance management.
• Proactively identify systemic 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.
• Represent the organization during internal audits and external regulatory inspections, providing subject‑matter expertise and influencing quality strategy and responses.
• Mentor engineers and cross‑functional partners, elevating quality engineering proficiency and ensuring consistent application of best practices across teams.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level