QA Engineer 2

Dexcom Inc.; San Diego (CA); Presencial; USD 72.000 - 119.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive benefits package

Career growth opportunities

Global collaboration

Tuition reimbursement / learning

Descripción de la vacante

Dexcom seeks a Quality Engineer to join our team in San Diego. You will independently execute quality investigations, root cause analyses, CAPAs, NCMRs, and MRB/disposition activities, implementing corrective actions to improve product quality and compliance.

You will apply Six Sigma, Lean, and process capability methods, support QMS improvements, and develop validation documentation for equipment, processes, and software, collaborating with multiple global teams.

Formación

• Bachelor’s degree in a technical discipline with 2–5 years of experience or Master’s degree with 0–2 years of experience.
• Experience supporting regulated manufacturing environments and quality engineering knowledge.
• Experience with IQ/OQ/PQ/PV, software V&V, and process validation activities.

Responsabilidades

• Lead quality investigations, including root cause analysis and CAPAs.
• Support validation and qualification of equipment, processes, test methods, and software.
• Contribute to risk assessments and implement appropriate controls.
• Represent Quality during audits and inspections.
• Collaborate with R&D, Regulatory Affairs, Manufacturing, Operations and global teams.
• Assist design transfer and commercialization activities with risk-based decisions.

Conocimientos

Risk management

Root cause analysis

Six Sigma

Process capability (Cpk/Ppk)

Statistical analysis

Data-driven decision making

Quality risk assessment

Cross-functional collaboration

Validation activities

Educación

Bachelor’s degree in Engineering or Chemistry

Master’s degree in related field (preferred)

Herramientas

JMP

Minitab

Excel

Descripción del empleo

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 attitude is important while working in a fast-paced environment and dealing with shifting priorities.

Where you come in:

• You support and independently execute quality investigations, including root cause analysis, CAPAs, NCMRs, and MRB/disposition activities, and implement corrective actions that improve product quality and compliance.
• You apply quality engineering and continuous improvement methodologies, such as Six Sigma, Lean Manufacturing, process capability analysis (Cpk/Ppk), Gage R&R, sampling plans, and risk-based problem solving.
• You support the effectiveness and continuous improvement of the Quality Management System through updates to procedures, process controls, validation practices, FMEAs, and other quality processes.
• You develop, review, and execute validation and qualification documentation for equipment, processes, test methods, and software, following applicable procedures and regulatory requirements.
• You provide quality engineering support for cross-functional projects, partnering with R&D, Regulatory Affairs, Manufacturing, Operations, Engineering, and global teams to meet project and quality objectives.
• You support design transfer and commercialization activities by reviewing requirements, evaluating manufacturing readiness, identifying quality risks, and helping transition new products and processes into manufacturing.
• You perform and document risk assessments, evaluate process and design changes, and recommend appropriate controls to support product performance and regulatory compliance.
• You represent Quality during audits and inspections within your assigned areas of responsibility.

What makes you successful:

• Your Engineering, Chemistry or similar degree from accredited College/University with experience supporting regulated manufacturing environments.
• Your quality engineering knowledge, including risk management, root cause analysis, Six Sigma, process capability analysis (Cpk/Ppk), statistical analysis, sampling plans, AQL, and data-driven decision-making.
• Your demonstrated experience supporting and executing validation activities, including IQ/OQ/PQ/PV, test method validation, software V&V, and process validation activities.
• Your experience supporting design transfer or commercialization activities, applying risk-based decision making to successfully transition new products and processes from development into high-volume manufacturing.
• Your strong technical aptitude with a hands-on approach, partnering directly with manufacturing teams to assess risk, troubleshoot issues, and drive sustainable process improvements.
• Your experience using JMP/Minitab/Excel or comparable statistical software.
• Your ability to communicate complex technical and compliance topics effectively.
• Your experience collaborating with Engineering, Operations, R&D, Regulatory Affairs, and global teams to deliver comprehensive quality solutions.
• Your experience with chemistry in manufacturing and associated risks.
• Your accountability, integrity, and ability to organize and prioritize work while supporting multiple quality initiatives in a fast-paced environment.

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:

• 0-5%

Experience and Education Requirements:

• Typically requires a Bachelor’s degree in a technical discipline, and a minimum of 2-5 years related experience or Master’s degree and 0-2 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.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom’s AAP may be viewed upon request by contacting Talent Acquisition at [e-mail].

If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at [e-mail].

Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: https://health1.meritain.com/app/public/#/one/insurerCode=MERITAIN_I&brandCode=MERITAINOVER/machine-readable-transparency-in-coverage?reportingEntityType=TPA_19874&lock=true

AI in Hiring Notice: We may use AI supported tools to help make our hiring process more efficient, consistent, and accessible for candidates around the world. All hiring decisions are made by people.

Salary:

$71,600.00 - $119,300.00