Tasks
Quality Management System (QMS)
Maintain and further develop the QMS in accordance with applicable standards and regulations.
Ensure effective document control, record maintenance, and system updates.
Prepare and maintain quality reports (e.g. Product Quality Reviews, Management Review inputs).
Support internal and external audits and follow-up on findings.
Regulatory Affairs
Ensure regulatory compliance in applicable markets.
Support product registrations, changes, and lifecycle activities.
Monitor regulatory changes and assess impact on products and processes.
Coordinate third-party testing activities as required.
Supplier & Customer Quality
Lead and support supplier quality activities, including qualification, monitoring, and nonconformities.
Support customer quality topics such as complaints, investigations, and feedback evaluation.
CAPA & Change Management
Support and manage CAPA activities, including investigations, root cause analysis, implementation, and effectiveness checks.
Support Engineering Change Orders (ECOs) with focus on quality, regulatory compliance, and documentation integrity.
Risk, PMS & Vigilance
Support Post Market Surveillance activities, including data collection, evaluation, and documentation.
Support risk management activities according to ISO 14971.
Ensure PMS and risk outputs are reflected in CAPA, labelling, and documentation.
About the position
Your key role is to maintain and continuously improve the Quality Management System and regulatory compliance of the organization. The role ensures that products, processes, suppliers, and documentation comply with applicable regulatory requirements and standards throughout the full pr