Senior Staff Quality Engineer

Dexcom Corporation (NASDAQ: DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Founded with the vision to transform diabetes management, Dexcom has spent 25 years pioneering an industry and is now expanding its mission to empower people to take control of their health through personalized, actionable insights. With thousands of passionate employees worldwide, Dexcom aims to improve human health on a global scale by reinventing biosensing-technology experiences.

About the role

As the Senior Staff QA Engineer, you will support Dexcom in delivering state-of-the-art innovative technology to patients while defining, supporting, and improving the processes that ensure quality and compliance. This role drives quality compliance and inspection readiness across products, processes, and systems, partnering cross-functionally to maintain audit readiness, identify compliance risks, and implement scalable quality solutions.

Responsibilities

• Drive inspection readiness programs, including mock audits, readiness assessments, and documentation preparedness.
• Establish and monitor audit readiness metrics.
• Implement proactive strategies to prevent repeat findings and improve overall quality system effectiveness.
• Influence stakeholders at all levels to drive consistent execution of quality and compliance processes.
• Mentor engineers and provide guidance on compliance best practices and audit preparedness.
• Lead complex investigations and drive systemic improvements by identifying compliance or procedural gaps, developing corrective and preventive actions, and securing cross-functional buy-in.
• Participate in internal audits and external regulatory inspections.
• Ensure adherence to design control requirements across products, processes, and systems.

Requirements

• Hands-on experience with FDA 21 CFR 820, ISO 13485, and related Quality Management System requirements, with the ability to interpret and apply them at a system and program level.
• In-depth understanding of Quality Compliance and Regulatory Compliance frameworks in a medical device environment.
• Proficiency in reviewing and interpreting complex technical documentation, engineering drawings, and specifications, and guiding others in doing the same.
• Strong proficiency in data analysis tools such as Excel and JMP, and the ability to guide teams in developing robust, data-driven decisions.
• Ability to communicate with clarity and influence across all levels of the organization, ensuring alignment with engineering, operations, leadership, and global partners.
• Experience formulating and driving implementation of comprehensive, cross-functional quality solutions while gaining alignment across stakeholders and global sites.
• Ability to independently organize, prioritize, and lead strategic initiatives while serving as a key contributor on cross-functional teams.
• Demonstrated initiative, ownership, and integrity in driving high-impact quality and compliance improvements.
• Ability to thrive in a dynamic environment and support broader quality and operations organizations as needed.

Qualifications

Typically requires a Bachelor’s degree in a technical discipline and a minimum of 13+ years of related experience, or a Master’s degree and 8+ years of equivalent industry experience, or a PhD and 5+ years of experience.

Benefits

• A front-row seat to life-changing CGM technology and the #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 employees, customers, and communities.

Pay

$128,600.00 - $214,400.00

Schedule

Travel required: 5-15%