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Dexcom

Markets real-time CGM devices and analytics

Document Control Specialist 3 - Evening Shift

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeAthenry, Co. Galway, Ireland

About the Job

Requirements

  • Proficiency with Microsoft Office Suite.
  • Ability to create reports in support of Quality Assurance systems.
  • Ability to use critical thinking to resolve issues.
  • Knowledge of electronic documentation systems.
  • Good understanding of Document Control requirements and processes outlined in ISO 13485 and 21 CFR Part 820.
  • Ability to apply acquired knowledge of Good Documentation Practices and Good Manufacturing Practices to daily tasks.
  • Typically requires a minimum of 4–6 years of related experience and an NFQ level 6 diploma or equivalent.
  • A minimum of 2 years of direct change management experience is required.

Responsibilities

  • Manage the change control system by reviewing, routing, and releasing change orders.
  • Assist with change-control system software training, support new-hire training, and provide other training as required.
  • Ensure projects are completed accurately and on time.
  • Interact with internal and external customers.
  • Support Quality in external and internal audits.
  • Monitor the status of in-process document changes to ensure timely revisions.
  • Assist customers with problem solving and offer possible solutions by applying job knowledge and skills to a wide range of tasks.
  • Scan, archive, and retrieve quality documents and records.
  • Issue controlled and uncontrolled documents.
  • Maintain service records for all departments.
  • Prepare requests for reproduction of documents.
  • Maintain external standards in accordance with standard operating procedures.
  • Support the development of documentation and configuration-control procedures.
  • Support the testing and improvement of change-control software and other supporting software.
  • Generate Quality Assurance reports as needed.

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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