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 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 to define, support, and improve the processes that get us there. A positive and team-oriented approach is important as you navigate shifting priorities, technical ambiguity, and complex cross-functional decisions.
Where you come in:- You lead complex, high-risk quality investigations, including root cause analysis, CAPAs, NCMRs/MRB, Health Hazard Evaluations (HHEs), and other product and process risk assessments, driving appropriate disposition and sustainable corrective actions.
- You provide technical leadership and guidance in quality engineering, including risk management, Six Sigma, process capability, statistical analysis, sampling strategies, and risk-based problem solving.
- You drive Quality Management System excellence by identifying systemic weaknesses and leading sustainable improvements to procedures, process controls, validation frameworks, FMEAs, and other quality processes across functions or sites.
- You define and provide technical leadership for risk-based validation and qualification strategies, including equipment and process qualification, Test Method Validation (TMV), measurement system analysis, and software V&V, ensuring compliance and product safety throughout the product lifecycle.
- You serve as a quality engineering technical lead across complex cross-functional initiatives, communicating technical and compliance issues clearly through written documentation, oral communication, and presentations to technical teams and senior leadership, while driving decisions and alignment across functions and sites.
- You provide risk-based quality leadership for design transfer, commercialization, and significant product or process changes, influencing technical decisions and establishing robust controls as products and processes scale to high-volume manufacturing.
- You represent Quality during internal audits and external regulatory inspections, providing subject matter expertise, leading responses to complex technical issues, and helping shape organizational quality and compliance strategy.
What makes you successful:- Your Chemical Engineering or similar degree from an accredited college or university, with substantial quality engineering experience in regulated manufacturing environments.
- Your advanced application of quality engineering principles, including risk management, root cause analysis, statistical analysis, process capability, sampling plans, measurement system analysis, and data-driven decision-making using tools such as JMP and Excel.
- Your demonstrated experience developing and evaluating risk-based validation strategies, including IQ/OQ/PQ/PV, Test Method Validation (TMV), measurement system analysis/Gage R&R, and software V&V.
- Your experience applying risk-based quality engineering to design transfer, commercialization, manufacturing issues, and process changes, with the ability to move between detailed technical problem solving and broader quality strategy.
- Your advanced written, oral, and presentation skills, with the ability to distill complex technical information, communicate risk and recommendations clearly, influence without direct authority, and present confidently to technical teams, cross-functional stakeholders, and senior leadership.
- Your demonstrated ability to operate independently with minimal direction, navigate ambiguity, establish technical direction, and lead multiple high-priority quality initiatives across functions or sites.
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:Experience and Education Requirements: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.
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:
$111,100.00 - $185,100.00
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