QMS Specialist

Hours: 40 hours per week (full-time)

Engagement: 6 month Freelance Contract

Key Responsibilities

• Ensure the Quality Management System remains compliant with internal procedures and applicable global regulatory requirements, including ISO 13485, EU MDR, FDA QSR/QMSR, and MDSAP frameworks.
• Lead the CAPA process from initiation to closure, including investigations, root cause analysis, implementation of corrective actions, effectiveness checks, and ongoing performance monitoring.
• Manage quality events arising from audits, non-conformities, complaints, supplier issues, and regulatory inspections, ensuring timely and effective resolution.
• Oversee the Change Control process, coordinating cross-functional assessments, approvals, implementation activities, and associated documentation updates.
• Maintain and administer the electronic QMS and SharePoint-based quality systems, ensuring accurate records, controlled documentation, and efficient system performance.
• Partner with cross-functional teams to drive continuous improvement initiatives, maintain inspection readiness, and strengthen overall quality system effectiveness.

Requirements

• Master's degree in Quality Assurance or a related discipline.
• 5-10 years' QA experience within the medical device industry.
• Strong working knowledge of ISO 13485, EU MDR 2017/745, FDA QSR/QMSR, and MDSAP requirements .
• Hands-on experience with CAPA, Change Control, Document Control, and electronic QMS platforms .