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The Quality Systems Assistant provides essential administrative support to the site Quality Team. This role ensures that all Quality Management System (QMS) and Manufacturing documentation is accurately maintained, controlled, and released in compliance with regulatory standards (ISO 9001 / ISO 13485).
Job Responsibility:
Document Control: Administer the maintenance and change control of Quality documentation using the Electronic Document Management System (eDMS)
Compliance Support: Coordinate the preparation and review of controlled documents to ensure they meet internal procedures and regulatory requirements
Operational Support: Provide QA administrative assistance to Manufacturing and Technical Operations to ensure seamless documentation release
Process Improvement: Assist in the continuous improvement of documentation workflows and site quality standards
Requirements:
Education: Scientific discipline or equivalent experience in a regulated administrative environment (e.g., Quality, Manufacturing, or Engineering)
Technical Skills: Proficient in Microsoft Office (Excel/Word). Experience with eDMS platforms is highly desirable
Competencies: Exceptional attention to detail and a methodical approach to tasks
Ability to strictly follow defined procedures and workflows
Strong communication skills and a collaborative mindset
Knowledge: Familiarity with ISO 9001 or ISO 13485 standards is preferred but not essential
Nice to have:
Experience with eDMS platforms is highly desirable
Familiarity with ISO 9001 or ISO 13485 standards is preferred but not essential