Sr QA Engineer jobs in United States
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Dexcom · 2 days ago

Sr QA Engineer

Dexcom Corporation is a pioneer and global leader in continuous glucose monitoring (CGM). The Sr QA Engineer will be responsible for executing and coordinating Corrective and Preventive Actions, supporting audits, and developing Quality Assurance dashboards to ensure compliance with quality standards and regulations.

DiabetesHealth DiagnosticsMedical DeviceSensor
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H1B Sponsor Likelynote

Responsibilities

Leads and Coordinates and ensures compliance to CAPA, HHA and NCE systems. Provide guidance as necessary to ensure appropriate depth of investigation and corrective and/or preventive actions. Assess effectiveness of corrective and preventive actions. Prepare QA Review Board meetings agenda and minutes
Aid in the design, development, validation, and deployment of Quality Assurance Metric Dashboards for all areas of Operations Quality Assurance in San Diego
QA Continuous Improvement Projects
May administer specific aspects of the quality system
Designs and applies company policies and procedures that help Dexcom achieve its quality policy and compliance with domestic and international regulations. Some examples include Equipment, Process, Software and Test Method Validation, Auditing, Calibrations, CAPA, Customer complaint processing, Document control, Nonconforming materials, Process controls, Receiving inspection, Training
Participates in internal audits, supplier audits to ensure systems comply with requirements and are effective
Participates as member of the design team. Activities may include assisting with defining design inputs; designing components and processes; verifying that design outputs satisfy design inputs
Applies risk management, validation, sample size, and external standards review and implementation activities
Coordinates the disposition of nonconforming materials with the Materials Review Board
Reads, writes, and understands specifications and inspection criteria to apply criteria using appropriate and properly configured inspection tools

Qualification

Quality Management SystemsCAPAFDA auditsStatistical analysisOraclePower BICertified Quality EngineerCollaborationProblem solvingPositive attitude

Required

Typically requires a Bachelors degree in a technical discipline with 5-8 years of related industry experience or a Masters Degree and 2-5 years of equivalent industry experience or a PhD and 0-2 years of experience
Direct experience with Quality Management Systems, Nonconforming Material, CAPA, HHA/HHE, Nonconforming Events, Internal and External Audits
Experience in FDA audits
Good understanding of QMS as applied to medical devices
Collaborative, able to work effectively and lead diverse functional groups
Demonstrates good judgment in selecting methods and techniques for problem solving and obtaining solutions
Can work well alone, normally receives little instruction on day-to-day work, general instructions on new assignments
A positive attitude is important while working in a fast-paced environment and dealing with shifting priorities
Experience with Oracle, Camstar, IQVIA, 1Factory, EtQ Reliance, Korber, SQL Servers, Power BI, Tableau
Experience with statistical analysis and statistical analysis software packages like Minitab and Jump

Preferred

Certified Quality Engineer, Certified Quality Auditor a plus

Benefits

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.

Company

Dexcom develops, manufactures, and distributes continuous glucose monitoring systems for diabetes management.

H1B Sponsorship

Dexcom has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (54)
2024 (41)
2023 (67)
2022 (75)
2021 (49)
2020 (36)

Funding

Current Stage
Public Company
Total Funding
$2.16B
Key Investors
RWI Group
2023-05-02Post Ipo Debt· $1B
2020-05-12Post Ipo Debt
2018-11-01Post Ipo Equity· $750M

Leadership Team

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Jacob Leach
Chief Operating Officer
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Matt Dolan
Executive Vice President, Strategy, Corporate Development & Dexcom Labs
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Company data provided by crunchbase