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Dexcom

Markets real-time CGM devices and analytics

Quality Technician 2 - Back End

Inspection & Test +1Confirmed live in the last 24 hours
Full-timeAthenry, Co. Galway, Ireland

About the Job

Requirements

  • Level 6 qualification in Quality or a related discipline.
  • At least 2 years of experience in a regulated industry, preferably in a medical device or similarly regulated manufacturing environment.
  • Knowledge of ISO 13485, 21 CFR Part 11, and 21 CFR 820.
  • Experience with cross-site or global system projects.
  • Audit experience with the Food and Drug Administration, BSI, or MDSAP.
  • Experience with manufacturing systems, Manufacturing Execution Systems, Enterprise Resource Planning, or Quality Management System applications.
  • Knowledge of Good Manufacturing Practice, Good Laboratory Practice, ISO requirements, and Six Sigma requirements.
  • Ability to read and interpret specifications, inspection criteria, and engineering drawings and apply requirements using appropriately configured inspection tools.
  • Intermediate computer skills, including effective use of Microsoft Office applications.
  • Ability to work independently with minimal supervision and collaboratively with cross-functional teams.
  • Strong documentation practices and attention to detail.

Responsibilities

  • Support Quality Engineering activities, including Change Order processing, Nonconformance Events, Nonconforming Material Reports, and Corrective and Preventive Action investigations.
  • Collect manufacturing and inspection data and perform inspections to support investigations led by Quality Engineers.
  • Maintain a regular presence on the manufacturing floor and assist the inspection team with questions about inspection methods, processes, and specifications.
  • Support Quality Engineering in ensuring compliance with internal procedures and external standards and regulations.
  • Update and maintain quality assurance procedures, protocols, and methods for processing materials into partially finished and finished products.
  • Ensure manufacturing and production processes comply with internal quality systems and applicable safety, quality, and regulatory requirements.
  • Support the investigation, assessment, verification, and disposition of nonconforming materials with cross-functional teams.
  • Perform routine line audits to verify that systems are compliant, effective, and operating as intended.
  • Provide day-to-day quality support to Quality Engineering and Operations by addressing production quality issues and supporting corrective actions.
  • Identify opportunities for quality and process improvement and contribute to continuous improvement initiatives.
  • Communicate concerns related to work processes, environmental impact, health, or safety to the manager in a timely manner.
  • Assist in training and mentoring junior technicians as required.
  • Perform additional duties assigned in support of Quality and Operations objectives.

Desired Qualifications

  • Experience applying quality systems in a regulated manufacturing environment with strong shop-floor presence and ownership of assigned quality systems.
  • Experience actively contributing to nonconformance investigations and Corrective and Preventive Action activities.
  • Understanding of Food and Drug Administration, ISO, and MDSAP requirements and ability to support inspections and audits.
  • Sound judgment and confident decision-making, including appropriate escalation of issues.

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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