Sr QA Engineer

Dexcom, Inc; Mesa (AZ); On-site; USD 87,000 - 145,000; Full time

Benefits offered by this job

Comprehensive benefits

Career development

Tuition reimbursement

Job summary

Dexcom seeks a Senior Quality Engineer to lead investigations, CAPA development, and strengthen quality systems across cross-functional teams. You will influence product design and drive data-driven decisions to ensure safety, reliability, and regulatory compliance of medical devices.

The role requires deep knowledge of FDA QSR, ISO 13485, and risk management; you will mentor engineers, reinforce quality processes, and partner with operations, R&D, and manufacturing to deliver compliant devices

Qualifications

• Bachelor's degree in a technical field with 5-8 years of related experience, or higher degrees with fewer years.
• Experience in quality engineering within medical devices is preferred.
• Knowledge of FDA QSR, ISO 13485, and risk management required.

Responsibilities

• Lead complex investigations and CAPA development.
• Develop and strengthen quality systems and drive data-driven decisions.
• Mentor engineers and promote risk-based thinking.
• Ensure products meet safety, reliability, and regulatory standards.

Skills

FDA QSR

ISO 13485

Risk management

Statistical tools

Root cause analysis

Validation

Problem solving

Leadership presence

Communication skills

Prioritization

Education

Bachelor's degree in a technical discipline

Tools

GLP

GMP

ISO 13485

Job description

The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health. We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.

Meet the team:

Our Quality organization is the backbone of Dexcom-ensuring 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. Their work safeguards patient outcomes, protects the integrity of the business, and reinforces trust with clinicians, regulators, and customers worldwide.

At the center of this mission, the Senior Quality Engineer plays a critical technical and leadership role. Operating as both a subject-matter expert and strategic problem-solver, the Staff QE leads complex investigations, develops and strengthens quality systems, influences product and process design, and drives data-driven decision making across the organization. They mentor engineers, shape best practices, elevate risk-based thinking, and ensure that manufacturing and design teams consistently deliver products that meet stringent regulatory and performance requirements. In essence, the Staff QE is a key architect of quality-bridging technical depth with cross-functional leadership to ensure safe, effective, and compliant medical devices reach patients who depend on them.

Where you come in:

• Your role will provide guidance across cross-functional teams
• You will implement and maintain quality assurance protocols and methods for processing materials into partially finished or finished products.
• You will assure compliance to in-house and/or external specifications and standards (i.e. GLP, GMP, ISO, Six Sigma).
• Complete complex investigations, CAPA development, and quality decision-making.
• Assist in high-visibility quality engineering projects with cross-functional teams
• Identify systemic issues and drive long-term corrective and preventive actions

What makes you successful:

• You will need an understanding of FDA QSR, ISO 13485, and risk-management requirements.
• Your knowledge in statistical tools, root cause analysis, validation, and problem-solving methodologies.
• Your strong leadership presence with the ability to influence without authority.
• Your communication skills, capable of presenting complex information clearly to technical and non-technical audiences.
• Your ability to thrive in a fast-paced environment and manage multiple priorities.
• Your passion for developing others and lifting team performance through coaching and example.

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 5-8 years related experience or Master's degree and 2-5 years equivalent industry experience or a PhD and 0-2 years 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.

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

To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.

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Salary:$87,000.00 - $145,000.00#DexcomUS