Dexcom

Dexcom

Staff QA Engineer

San Diego, California · Staff+

Sponsorship not specified$111k-$185kDetected 12 days ago
SQLData AnalysisData VisualizationStatisticsAuditingRecruitingCustomer SupportFDA RegulatoryMedical DevicesProblem SolvingRegulatory Affairs

About the role

  • 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.
  • That means personalized, actionable insights aimed at solving important health challenges.

Responsibilities

  • Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

Requirements

  • Typically requires a Bachelor's degree in a technical discipline, and a minimum of 8-12 years related experience or Master's degree and 5-7 years equivalent industry experience or a PhD and 2-4 years of experience.
  • Travel Required:

Nice to have

  • Direct experience with Quality Management Systems, Nonconforming Material, CAPA, HHA/HHE, Nonconforming Events, Internal and External Audits.
  • Experience with Oracle, Camstar, IQVIA, 1Factory, EtQ Reliance, SQL Servers, Google Big Query.
  • Experience with statistical analysis and statistical analysis software packages like Minitab and Jump
  • Experience in FDA audits
  • 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.
  • Certified Quality Engineer, Certified Quality Auditor a plus.

Skills

  • Leads and coordinates the Non-Conforming Events (NCE) system.
  • May administer specific aspects of the quality system.
  • Participates in internal and external audits to ensure systems comply with requirements and are effective.
  • Apply risk management, validation, sample size, and external standards review and implementation activities.
  • Coordinates the disposition of nonconforming materials with the Materials Review Board.
  • QA Continuous Improvement Projects
  • Assumes and performs other duties as assigned.

Compensation

  • $111,100.00 - $185,100.00

Benefits

  • A full and comprehensive benefits program.
  • Access to career development through in-house learning programs and/or qualified tuition reimbursement.
  • Experience and Education Requirements:

Company info

  • 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.
  • Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM).
  • As a Staff QA Engineer your role will be responsible for defining requirements and development of analytic dashboards, validating, and deploying Quality Assurance data and information dashboards with focus on Manufacturing Controls, Quality Management Systems and New Product Development.
  • This role is also responsible for executing and coordinating Site Management Reviews for the San Diego site and coordinating data transfer for Corporate Management Reviews.
  • Also, this role leads and coordinates the Non-Conforming Events (NCE), support Internal and External Audits.
  • This position will interface with different cross functional groups (Operations Data Analytics, Customer Advocacy, Quality Engineering, Software Engineering, Software Test, Regulatory Affairs, and others).
  • The Staff Quality Engineer role provides Quality Assurance Engineering and Compliance expertise, and technical support to Sustaining Quality Engineering and Quality Control teams to ensure they have the necessary information to make quality decisions, facilitate compliance to Dexcom's Quality Management System and international regulation standards (e.g. 21 CFR Part 11, 801, 803, 820; ISO 13485, ISO 14971).
  • A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community.

Equal opportunity

  • The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons.
  • An Equal Opportunity Employer.
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This listing is sourced directly from Dexcom's careers page and normalized into a canonical job model.