- 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.