Quality Specialist

Responsible for maintaining, implementing, and continuously improving the company’s Quality Management System to ensure compliance with ISO 9001, ISO 13485, customer requirements, and applicable regulatory standards.

• Maintain and continuously improve the Quality Management System, including relevant procedures, work instructions, records, and supporting documentation.
  
• Coordinate the implementation of and compliance with ISO 9001 and ISO 13485 requirements across relevant functions.
  
• Plan and conduct internal audits and coordinate certification audits, customer audits, and other external assessments.
  
• Monitor audit findings, non-conformities, CAPA activities, and corrective actions to ensure timely closure and effective implementation.
  
• Manage quality-related documents and records in accordance with established document control requirements.
  
• Coordinate risk assessments, quality objectives, KPI monitoring, and continuous improvement initiatives.
  
• Deliver ISO and QMS awareness training and provide guidance to departments in implementing quality system requirements.
  
• Prepare QMS reports and support Management Review activities.
  
• Monitor updates to applicable standards and regulatory requirements and ensure necessary actions are implemented accordingly.
  
• Request relevant departments to provide information and documentation required for QMS and audit activities.
  
• Recommend improvements to QMS procedures, processes, and related documentation.
  
• Request and follow up on corrective actions for identified non-conformities and promptly escalate significant quality risks or compliance issues to management.
  
• Perform other duties as assigned by direct supervisors.
  

• Bachelor’s degree in Engineering or another relevant discipline.
  

• At least 3 years of experience in Quality Management or QMS within a manufacturing environment.
  
• Strong knowledge and hands-on experience with ISO 9001 and ISO 13485.
  
• Experience with ISO 14001 and ISO 45001 is considered an advantage.
  
• Practical experience in QMS implementation, internal audits, and external or customer audits is required.
  
• Language Skills
  
• Good command of English for professional communication and documentation.
  

• Proficiency in Microsoft Office.
  
• Experience using quality management systems or electronic document management tools is an advantage.
  

• Strong analytical, problem-solving, communication, and cross-functional coordination skills.
  
• Proactive, responsible, and systematic, with the ability to work effectively and independently.