Staff QA Engineer

DexCom • San Diego, CA

5d

About The Position

Dexcom is seeking a Staff QA Engineer to provide technical leadership in quality engineering for its continuous glucose monitoring products. The role supports the development and improvement of processes that bring innovative technology to patients, working collaboratively across functions and sites while navigating changing priorities, technical ambiguity, and complex decisions.

The Staff QA Engineer leads high-risk quality investigations and corrective actions; provides expertise in quality engineering and risk management; drives improvements to the Quality Management System; and defines risk-based validation and qualification strategies. The role also leads quality engineering work across cross-functional initiatives, supports design transfer, commercialization, and product or process changes, and represents Quality during audits and regulatory inspections. This position requires the ability to work independently, influence stakeholders without direct authority, and communicate technical and compliance matters to teams and senior leadership.

Travel required: 0–5%.

Requirements

• Bachelor’s degree in a technical discipline and 8–12 years of related experience; or a Master’s degree and 5–7 years of equivalent industry experience; or a PhD and 2–4 years of experience.
• A degree in Chemical Engineering or a similar discipline from an accredited college or university.
• Substantial quality engineering experience in regulated manufacturing environments.
• 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.
• 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.
• Experience applying risk-based quality engineering to design transfer, commercialization, manufacturing issues, and process changes, moving between detailed technical problem solving and broader quality strategy.
• Advanced written, oral, and presentation skills; ability to explain complex technical information, communicate risk and recommendations clearly, influence without direct authority, and present to technical teams, cross-functional stakeholders, and senior leadership.
• Ability to work independently with minimal direction, navigate ambiguity, establish technical direction, and lead multiple high-priority quality initiatives across functions or sites.

Responsibilities

• Lead complex, high-risk quality investigations, including root cause analysis, CAPAs, NCMRs/MRB, Health Hazard Evaluations (HHEs), and other product and process risk assessments; drive appropriate disposition and sustainable corrective actions.
• Provide technical leadership and guidance in quality engineering, including risk management, Six Sigma, process capability, statistical analysis, sampling strategies, and risk-based problem solving.
• Identify systemic weaknesses and lead sustainable improvements to procedures, process controls, validation frameworks, FMEAs, and other quality processes across functions or sites.
• 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.
• Serve as a quality engineering technical lead across complex cross-functional initiatives; communicate technical and compliance issues through documentation, presentations, and oral communication; and drive decisions and alignment across functions and sites.
• Provide risk-based quality leadership for design transfer, commercialization, and significant product or process changes, influencing technical decisions and establishing controls as products and processes scale to high-volume manufacturing.
• Represent Quality during internal audits and external regulatory inspections, provide subject matter expertise, lead responses to complex technical issues, and help shape organizational quality and compliance strategy.

Benefits

• Full and comprehensive benefits program.
• Growth opportunities on a global scale.
• Career development through in-house learning programs and/or qualified tuition reimbursement.
• Opportunity to work with continuous glucose monitoring technology at an innovative, industry-leading organization.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior