Quality Assurance (QA) Engineer - Medical Devices

About the role

A Quality Engineer position in the Quality Department, responsible for managing customer feedback, quality issues and compliance with medical device quality standards.

Key responsibilities

• Manage and follow up on customer feedback, complaints and quality issues, ensuring timely investigation, root cause analysis, corrective actions and resolution.
• Establish, maintain and improve inspection criteria, specifications and quality standards for incoming materials, in-process production and finished products.
• Identify, document and manage product quality issues and non-conformances (NCRs), including root cause analysis and corrective and preventive actions.
• Authorize product release and review and approve Certificates of Conformance (COC), Certificates of Analysis (COA) and inspection results.
• Review and approve Device History Records (DHR) to ensure compliance with established requirements.
• Develop, implement, review and maintain quality procedures, work instructions, inspection methods and quality control measures.
• Support and take part in internal, external and customer audits.
• Analyse product quality data and quality objectives, identifying trends and improvement opportunities.

Required profile

• Degree or diploma in Chemical, Material, Manufacturing, Science and Engineering, or a related discipline; fresh graduates are welcomed.
• 2-5 years' experience in medical device Quality Assurance.
• Strong analytical, problem-solving and critical-thinking skills, with the ability to show initiative.

Required skills

• Proficiency in Microsoft Office applications.
• Familiarity with quality control tools and knowledge of ISO 13485 and/or ISO 9001 requirements.
• An ISO 13485:2016 certified internal auditor is advantageous.