Evening-Shift Doc Control Specialist 3 | ISO 13485 Focus

Dexcom Inc.; Athenry; Remote; EUR 41,000 - 53,000; Full time

Benefits offered by this job

Shift allowance 20%

Benefits program

Career development

Job summary

Dexcom in Athenry, Ireland seeks a Document Control Specialist 3 for an evening shift to sustain the change control system and support all document control activities in line with 21 CFR Part 820, ISO 13485, and GDP/GMP standards. Proficiency with Microsoft Office and electronic documentation systems is required.

The role involves training support, audit participation, and interaction with internal and external customers, ensuring timely revisions and controlled document issuance.

Qualifications

• Typically requires 4-6 years of related experience and an NFQ Level 6 diploma or equivalent.
• Experience with ISO 13485 and 21 CFR Part 820 is preferred.
• Proficiency with Microsoft Office Suite is essential.
• Knowledge of GDP and GMP to daily tasks.

Responsibilities

• Manage the change control system and review, route and release change orders.
• Assist in change control software training and 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 status of in-process document changes and revisions.
• Assist customers with problem solving using job knowledge.
• Scan, archive and retrieve quality documents and records.

Skills

Microsoft Office Suite

Critical thinking

Attention to detail

GDP/GMP knowledge

Education

NFQ Level 6 Diploma or equivalent

Tools

Document management system

Job description

Dexcom in Athenry, Ireland seeks a Document Control Specialist 3 for an evening shift to sustain the change control system and support all document control activities in line with 21 CFR Part 820, ISO 13485, and GDP/GMP standards. Proficiency with Microsoft Office and electronic documentation systems is required.

The role involves training support, audit participation, and interaction with internal and external customers, ensuring timely revisions and controlled document issuance.