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.
Where you come in: - 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.
What makes you successful: - 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.
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: Education and Experience:- 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.
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.
Salary:
$128,600.00 - $214,400.00
