Document Control Specialist - Evening Shift (ISO/GMP QA)

36 Dexcom International Limited; Athenry; On-site; EUR 41,000 - 53,000; Full time

Benefits offered by this job

Comprehensive benefits

Career development

Global growth opportunities

Tuition reimbursement

Dexcom community

Job summary

Dexcom Ireland is seeking a Quality Assurance professional to manage the change control system and ensure accurate document control across GMP/GDP processes. The role will review change orders, assist in training, and support audits in a fast-paced CGM environment.

The position requires 4–6 years of related experience and an NFQ level 6 diploma. The annual base salary ranges from €41,055 to €53,130, with an evening shift allowance of 20%. Final offer depends on qualifications and experience.

Qualifications

• Proficient with Microsoft Office Suite.
• Ability to create reports in support of QA systems.
• Able to apply critical thinking to resolve issues.
• Knowledge of electronic documentation systems.
• Good understanding of Document Control per ISO 13485 and 20 CFR part 820.
• Ability to apply GDP and GMP knowledge to daily tasks.

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 audits (internal and external).
• Monitor in-process document changes for timely revisions.
• Assist customers with problem solving using job knowledge.
• 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 per SOPs.
• Support development of documentation and configuration control procedures.
• Support testing and improvement of change control software and other supporting software.
• Generate QA reports as needed.

Skills

Microsoft Office

Report writing

Critical thinking

Electronic documentation systems

ISO 13485 knowledge

GDP & GMP knowledge

Shift work

Education

NFQ level 6 diploma

Job description

Dexcom Ireland is seeking a Quality Assurance professional to manage the change control system and ensure accurate document control across GMP/GDP processes. The role will review change orders, assist in training, and support audits in a fast-paced CGM environment.

The position requires 4–6 years of related experience and an NFQ level 6 diploma. The annual base salary ranges from €41,055 to €53,130, with an evening shift allowance of 20%. Final offer depends on qualifications and experience.