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Dexcom

Markets real-time CGM devices and analytics

Staff QA Engineer

Quality Engineering +1Confirmed live in the last 24 hours
Full-timeSan Diego, CA, USA$111.1k - $185.1k

About the Job

Requirements

  • Typically requires a Bachelor's degree in a technical discipline and a minimum of 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.
  • Deep, hands-on experience with FDA 21 CFR 820, ISO 13485, and related Quality Management System requirements, including interpreting and applying them at a system and program level.
  • Proficiency reviewing and interpreting complex technical documentation, engineering drawings, and specifications, and guiding others in doing the same.
  • Advanced skills in root cause analysis, Six Sigma methodologies, structured problem solving, test method validation, software validation, process validation, process capability such as Cpk/Ppk, lean manufacturing, sampling plans, and statistical analysis.
  • Proficiency in data analysis tools such as Excel and JMP, and ability to guide teams in making data-driven decisions.
  • Ability to formulate and drive implementation of comprehensive, cross-functional quality solutions and gain alignment across stakeholders and global sites.
  • Ability to independently organize, prioritize, and lead strategic initiatives while serving as a key contributor on cross-functional teams.
  • Ability to support broader quality and operations organizations as needed.

Responsibilities

  • Serve as a technical leader on new high-volume manufacturing automation equipment development teams by interpreting and guiding regulatory requirements, shaping equipment and process design requirements, influencing risk-based design decisions, and architecting validation strategies across programs.
  • Drive Design Control and design transfer strategy for new products, ensuring scalable, high-volume manufacturing readiness across global sites; partner with Operations to optimize transition from pilot builds through commercial automation deployment.
  • Provide manufacturing quality engineering leadership for development, process validation, and commercialization of new processes; lead complex investigations, guide MRB decision-making, and drive systemic improvements across equipment and process designs.
  • Lead alignment across multi-level, cross-functional, and international teams on complex technical and compliance topics, setting direction and resolving ambiguities to ensure consistent implementation across sites.
  • Provide expert-level guidance in strengthening and governing the Quality Management System, including FMEA methodology, process validation architecture, CAPA strategy, process controls, and nonconformance management.
  • Identify systemic compliance or procedural gaps across programs or sites and lead teams developing and implementing corrective and preventive actions with cross-functional buy-in.
  • Represent the organization during internal audits and external regulatory inspections, providing subject-matter expertise and influencing quality strategy and responses.
  • Mentor engineers and cross-functional partners, elevating quality engineering proficiency and ensuring consistent application of best practices across teams.
  • Travel 5–15% as required.

About the Company

Dexcom

Markets real-time CGM devices and analytics

Dexcom makes continuous glucose monitoring (CGM) systems to help people manage diabetes. Its core product, the Dexcom G6, uses a wearable sensor and transmitter to deliver real-time glucose readings to a display or smartphone without finger-prick calibrations. Dexcom differentiates itself with a full CGM ecosystem, including Dexcom CLARITY data analytics and subscription services for sharing data with clinicians and caregivers. The company's goal is to improve the quality of life for people with diabetes by providing accurate, easy-to-use glucose monitoring and actionable data.

Company size
5,001-10,000
Company stage
IPO
Headquarters
San Diego, CA
Founded
1999

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