Quality Document Control Senior Assistant

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About the opportunity

We are looking for a motivated and detail-oriented Document Control Senior Assistant to join our Quality Assurance team. In this role, you will support quality management processes, ensure compliance with internal procedures and regulatory requirements, and contribute to the efficient management of quality documentation and records.

This position may require occasional work between 2:00 PM and 10:00 PM, according to a pre-arranged schedule for several weeks throughout the year. These are not regular working hours; however, flexibility to work during this time frame is a requirement of the role.

Your tasks include

• Supporting the maintenance and administration of Quality Management System (QMS) documentation.
• Coordinating document control activities, including review, approval, distribution, and archival of quality documents.
• Assisting in the preparation, execution, and follow-up of internal and external audits.
• Maintaining quality records and ensuring documentation accuracy and completeness.
• Supporting training administration activities and tracking of training records.
• Monitoring and following up on quality-related actions and documentation tasks.
• Collaborating with stakeholders across departments to ensure compliance with quality processes and procedures, participating in continuous improvement initiatives and quality projects as needed, and providing administrative support to the Quality Assurance team.

Your profile

• Previous experience in Quality Assurance, Document Control, or a related administrative role.
• Understanding of document compliance principles and quality standards, preferably ISO 9001, ISO 13485, QSR 820, 21 CFR 820, or 21 CFR Part 11.
• Strong organizational skills and attention to detail, with the ability to manage multiple priorities and meet deadlines.
• Good communication and interpersonal skills, combined with a collaborative, proactive, solution-oriented, and positive approach to teamwork.
• Proficiency in Microsoft Office applications; experience working with electronic quality management or document management systems is an advantage.
• Good command of English, both written and spoken. 
• Completed or ongoing degree, preferably in Quality Management, Information Technology (IT) Support, Business Administration, or a related field.
• Openness to working under a one-year fixed-term contract.