Document Control Specialist
We are seeking a highly organized and detail-oriented individual to join our Quality Systems team as a Document Control Specialist. Based in our office, you will be responsible for managing document and change control workflows within our electronic Quality Management System (eQMS) and providing essential support to our quality teams.
Responsibilities:
* Manage document workflows: ensure proper routing, review for completeness and formatting, and maintain compliance with industry standards.
* Support internal and external audits and organize practicalities.
* Archive and maintain training records and other quality documentation.
* Provide general support to the quality teams, such as complaint closure, KPI reporting, scheduling, and other administrative tasks.
Profile:
* Minimum bachelor's degree or equivalent by experience.
* At least 2 years of experience in document control and/or change management within a regulated industry strongly preferred.
* Knowledge of Good Documentation Practices (GDP) and document control principles.
* Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint); experience with electronic Quality Management System (eQMS) is preferred.
* Familiarity with ISO 13485, FDA 21 CFR Part 820, MDR, or AS9100 compliance is a plus.
* Fast learner, proactive mindset and able to thrive in a fast-paced environment.
* High attention to detail, integrity and strong problem-solving skills.
* Excellent communication and collaboration skills, capable of delivering outstanding internal customer support.
* Good knowledge of English; knowledge of Dutch is preferable.
Requirements:
* A competitive salary and additional non-statutory benefits.
* Career opportunities in a global company with growth opportunities.