QA Officer

About the role

This role involves maintaining and updating Quality Management System (QMS) documentation in compliance with ISO 9001, ISO 13485 and applicable regulatory requirements, with a focus on continual improvement. You will lead or participate in risk management activities such as process FMEAs in accordance with ISO 14971, and manage QA/QC activities for the MedTech Section to ensure product specifications, customer requirements and regulatory compliance are consistently met.

Key responsibilities

• Maintain and update QMS documentation in compliance with ISO 9001, ISO 13485 and applicable regulatory requirements and continual improvement of the QMS
• Lead or participate in risk management activities (e.g. process FMEAs) in accordance with ISO 14971
• Manage QA/QC activities of the MedTech Section to ensure product specifications, customers and applicable regulatory requirements are consistently met
• Guide QA/QC personnel to ensure daily inspection and/or test activities are performed effectively and according to QMS documents, and maintain products identification and traceability
• Ensure inspection methods, quality controls and documentation are properly established to support smooth production operations and resolve quality issues effectively
• Prepare and review Device History Records and recommend Final Product Release
• Participate actively in customer complaint investigations and conduct root cause analysis to identify effective corrective and preventive actions
• Review non-confirming products and determine appropriate disposition according to quality requirements, analyse trends and follow up on improvement actions
• Act as an internal auditor to ensure compliance with ISO 13485, support third-party and customer audits and assist in audits closure activities
• Prepare and maintain documentation for pre-market regulatory requirements and interface with authorized representative or regulatory authority

About you

• At least 2 years working experience in QA
• Familiar with ISO 9001, ISO 13485 and QMS requirements
• Familiarity with quality tools such as FMEA, CAPA and root cause analysis
• Able to conduct internal QMS Audit
• Good writing and communication skills
• Able to work independently and collaborate effectively with cross-functional teams