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About the Company:
Sterling Engineering Ltd - Ireland & Europe is a leading manufacturer of medical devices seeking a highly skilled Document Controller to join their team in Galway. As a key member of the project team, you will be responsible for managing project documentation, ensuring compliance with regulatory requirements, and maintaining accurate records throughout the project lifecycle.
Responsibilities:
- Manage and control all project-related documentation, including design drawings, specifications, validation records, and change requests.
- Ensure all documentation aligns with GMP, FDA, ISO 13485, and internal quality standards.
- Implement document control procedures, track revisions, and ensure stakeholders have access to the latest versions.
- Work closely with engineering, construction, and validation teams to manage documentation workflows efficiently.
- Ensure document traceability and accessibility for internal and external audits.
- Manage electronic document management systems (EDMS) and ensure data integrity.
- Provide guidance to project teams on document control procedures and best practices.
Requirements:
- Proven experience in a Document Controller role.
- Knowledge of GMP, FDA, ISO 13485, and GDP.
- Proficiency in using EDMS.
- Strong organisational and administrative skills.
- Ability to work under pressure in a fast-paced environment.
- Excellent communication and teamwork skills.
