QA Engineer 2
Dexcom
Summary
Our Quality organization ensures that every product released to patients meets the highest standards of safety, reliability, and regulatory compliance. As a cross-functional partner to Operations, R&D, Regulatory, and Manufacturing, the Quality team drives a culture of excellence by embedding robust processes, rigorous risk management, and continuous improvement into every stage of the product lifecycle.
Job description
Meet the team
Our Quality organization ensures that every product released to patients meets the highest standards of safety, reliability, and regulatory compliance. As a cross-functional partner to Operations, R&D, Regulatory, and Manufacturing, the Quality team drives a culture of excellence by embedding robust processes, rigorous risk management, and continuous improvement into every stage of the product lifecycle.
The Quality Engineer II plays a critical technical and leadership role, operating as both a subject-matter expert and strategic problem-solver. The Quality Engineer leads complex investigations, develops and strengthens quality systems, influences product and process design, and drives data-driven decision making across the organization.
Where you come in
- Implement and maintain quality assurance protocols and methods for processing materials into partially finished or finished products.
- Ensure compliance to in-house and/or external specifications and standards (i.e. GLP, GMP, ISO, Six Sigma).
- Complete investigations into nonconformances.
- Assist in high-visibility quality engineering projects with cross-functional teams.
- Assist in identifying systemic issues and drive long-term corrective and preventive actions.
What makes you successful
- Understanding of FDA QSR, ISO 13485, and risk-management requirements.
- Knowledge in statistical tools, root cause analysis, validation, and problem-solving methodologies.
- Communication skills, capable of presenting complex information clearly to technical and non-technical audiences.
- Ability to thrive in a fast-paced environment and manage multiple priorities.
- Passion for developing others and lifting team performance through coaching and example.
Experience and Education Requirements
Typically requires a Bachelor's degree in a technical discipline and 2–5 years of related experience, or a Master's degree and 0–2 years of equivalent industry experience.
Travel Required
0-5%
Requirements
- Bachelor's degree in a technical discipline and 2–5 years of related experience, or a Master's degree and 0–2 years of equivalent industry experience
- Understanding of FDA QSR, ISO 13485, and risk-management requirements
- Knowledge in statistical tools, root cause analysis, validation, and problem-solving methodologies
- Communication skills, capable of presenting complex information clearly to technical and non-technical audiences
- Ability to thrive in a fast-paced environment and manage multiple priorities
- Passion for developing others and lifting team performance through coaching and example
Benefits
- Comprehensive benefits program
- Growth opportunities
- Career development
- Tuition reimbursement
Company overview
Dexcom, Inc. is a pioneering American healthcare company specializing in the development, manufacturing, and distribution of continuous glucose monitoring (CGM) systems for diabetes management. Founded in 1999 and headquartered in San Diego, California, Dexcom has transformed diabetes care through innovative biosensing technology that provides real-time glucose readings. The company's flagship products, including the G-series CGM systems, offer industry-leading accuracy and extended wear times, with the latest G7 model providing up to 15.5 days of continuous monitoring. As a publicly traded company listed on Nasdaq (DXCM) and a component of both the Nasdaq-100 and S&P 500 indices, Dexcom operates globally with manufacturing facilities in Arizona, Malaysia, and Ireland. With over 10,300 employees worldwide, the company generates approximately $4 billion in annual revenue and maintains strategic partnerships with major healthcare technology companies. Dexcom's mission focuses on empowering people with diabetes to take control of their health through advanced monitoring solutions that improve clinical outcomes and quality of life.