Description

As a Quality System Specialist, you will ensure compliance with regulations and support the Site Quality System. Your role involves guiding departments, leading audits, tracking KPIs, and providing training to maintain high-quality standards.

Requirements

• •Minimum 3 years’ experience in Quality Assurance of medical devices
• •Previous experience in quality processes for medical devices
• •Experience in GMP and other Regulatory compliance requirements
• •Analytical and problem-solving skills
• •Ethics and integrity
• •Ability to understand and adapt to different cultures and market needs
• •Fluency in English both spoken and written
• •Bachelor’s degree in Life Science or Engineering
• •Certification in Purchasing or Supply Chain Management (e.g., CIPS, APICS)
• •Certified internal auditor to ISO 13485
• •Previous experience in quality management systems for medical device manufacturing organizations
• •Certified internal auditor to ISO 13485

Tasks

• •Build and maintain the Site Quality Management System
• •Oversee implementation of quality assurance procedures, including change control
• •Lead internal and supplier audits
• •Support external audits
• •Track key performance indicators (KPIs)
• •Lead and contribute to corrective and preventive actions (CAPA) and non-conformances (NCs)
• •Contribute to site Quality Assurance and Regulatory Affairs (QARA) projects
• •Provide training on quality assurance procedures
• •Conduct supplier audits for qualification

Benefits