Senior Staff Quality Engineer

Dexcom • San Diego, CA

5d • $128,600 - $214,400

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. As the Senior Staff QA Engineer, 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.

Requirements

• You have 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.
• In-depth understanding of Quality Compliance and Regulatory Compliance frameworks in a medical device environment.
• You are proficient at reviewing and interpreting complex technical documentation, engineering drawings, and specifications, and you can guide others in doing the same.
• 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.

Responsibilities

• Serves as a Sr Staff Quality Engineer responsible for driving quality compliance and inspection readiness across products, processes, and systems.
• This role partners cross-functionally to ensure the organization maintains a continuous state of audit readiness, proactively identifies compliance risks, and implements scalable, sustainable quality solutions.
• 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.
• You lead complex investigations and drive systemic improvements
• You proactively identify systemic compliance or procedural gaps across programs or processes and lead the teams that develop and implement corrective and preventive actions with cross functional buy‑in.
• Participate in internal audits and external regulatory inspections.
• You ensure adherence to design control requirements across products, processes, and systems.

Benefits

• 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.

What This Job Offers

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