Quality Systems Specialist

About the role

The Quality Systems Specialist is responsible for developing, implementing and maintaining the organisation's Quality Management System (QMS) to ensure products, services and processes consistently meet regulatory requirements, industry standards and customer expectations.

Key responsibilities

• Design, deploy and continuously improve the QMS, including documentation, change control and CAPA processes.
• Coordinate internal and external audits, prepare audit evidence and manage audit findings.
• Monitor quality performance metrics, investigate non‑conformities and drive corrective and preventive actions.
• Conduct risk assessments, support certification activities and maintain quality records.
• Collaborate with QA, operations, engineering, manufacturing and regulatory teams to embed a culture of continuous improvement.

Required profile

• Bachelor's degree in Quality Management, Engineering, Life Sciences, Business Administration or a related field.
• Proven experience in quality systems, compliance or regulatory affairs within a regulated industry.
• Strong knowledge of ISO 9001, ISO 13485, GMP, GLP, GDP and related standards.
• Experience with document control, change control, deviation management, risk assessment and audit preparation.
• Excellent analytical, problem‑solving and communication skills.

Required skills

• ISO 9001, ISO 13485, GMP, GLP, GDP
• Document control and change control
• CAPA and deviation management
• Risk assessment and audit preparation
• Internal and supplier audit execution
• Root cause analysis and continuous improvement
• Microsoft Office Suite
• Quality management software, document management systems or ERP platforms
• Lean, Six Sigma, FMEA, statistical process control (SPC)