Document Control Specialist 3 – Evening Shift (ISO-13485)

Dexcom Ireland - Athenry; Athenry; On-site; EUR 41,000 - 53,000; Full time

Benefits offered by this job

Full benefits program

Growth opportunities

Tuition reimbursement

Career development

Job summary

Dexcom Ireland is seeking a Document Control Specialist 3 to sustain the change control system and support all document control activities in line with 21 CFR Part 820 and ISO-13485. The role requires proficiency in Microsoft Office and strong analytical skills, with annual base salary shown below.

This is a fixed evening shift role (Mon-Fri, 3:30 PM - 12 Midnight) with a 20% shift allowance. You will engage with internal/external customers and participate in audits, ensuring timely revisions of

Qualifications

• Typically requires a minimum of 4-6 years of related experience.
• NFQ Level 6 diploma or equivalent.

Responsibilities

• Manage the change control system, 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 both 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 using job knowledge and skills.
• Scan, archive and retrieve quality documents and records.
• Issue controlled and uncontrolled documents.
• Maintain service records of all departments.
• Prepare requests for reproduction of documents.
• Maintain external standards in accordance with SOPs.
• Support the development of documentation and configuration control procedures.
• Support testing and improvement of the change control software and other supporting software.
• Generate Quality Assurance reports as needed.

Skills

Critical thinking

Issue resolution

Quality mindset

GDP/GMP knowledge

Education

NFQ Level 6 diploma or equivalent

Tools

Microsoft Office Suite

Job description

Dexcom Ireland is seeking a Document Control Specialist 3 to sustain the change control system and support all document control activities in line with 21 CFR Part 820 and ISO-13485. The role requires proficiency in Microsoft Office and strong analytical skills, with annual base salary shown below.

This is a fixed evening shift role (Mon-Fri, 3:30 PM - 12 Midnight) with a 20% shift allowance. You will engage with internal/external customers and participate in audits, ensuring timely revisions of