Dexcom
Senior Staff Quality Engineer
San Diego, California · Staff+
Sponsorship not specified$129k-$214kDetected 12 days ago
Data AnalysisComplianceExcelRecruitingFDA RegulatoryMedical DevicesLeadership
About the role
- 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.
- That means personalized, actionable insights aimed at solving important health challenges.
Responsibilities
- 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.
- 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.
- 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.
- You ensure adherence to design control requirements across products, processes, and systems.
- Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
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.
- 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.
- Typically requires a Bachelor's degree in a technical discipline, and a minimum of 13+ years related experience or a Master's degree and 8+ years equivalent industry experience or a PhD and 5+ years of experience.
- Travel Required:
Compensation
- $128,600.00 - $214,400.00
Benefits
- A full and comprehensive benefits program.
- Access to career development through in-house learning programs and/or qualified tuition reimbursement.
- Education and Experience:
Company info
- 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.
- Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM).
- 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.
- A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community.
- Growth opportunities on a global scale.
Equal opportunity
- The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons.
- An Equal Opportunity Employer.
This listing is sourced directly from Dexcom's careers page and normalized into a canonical job model.