Quality Engineer

Job Description

• Conduct assessments and reviews of supplier qualification, performance, and process capability
• Investigate, analyze, and resolve supplier quality issues, with appropriate follow-up
• Manage customer feedback and complaints, ensuring timely investigation and resolution
• Support and participate in internal, external, and customer audits
• Perform evaluation, verification, and validation of new parts and samples
• Establish and maintain inspection criteria and standards for incoming, in-process, and finished products
• Identify and manage product quality issues and Non-Conformances (NCRs), support CAPA activities, and drive continuous improvement initiatives
• Authorize product release review and approve Certificates of Conformance (COC), Certificates of Analysis (COA), and inspection results
• Conduct monthly analysis of product quality data and quality objectives, identifying trends and improvement opportunities
• Review and approve Device History Records (DHR) to ensure compliance with requirements
• Participate in new product/project development and commercial product quality control activities
• Drive and maintain effective change management and change control processes

Job Requirements

• Diploma or Bachelor's degree in a relevant field
• 2-5 years experience in medical device Quality Assurance
• Proficiency in Microsoft Office and familiarity with quality control tools
• Working knowledge of ISO 9001 and/or ISO 13485 requirements
• Ability to use measuring devices (e.g., pin gauges, tensile machine)
• Strong analytical, problem-solving, and critical-thinking skills, with a proactive, self-driven approach
• ISO 13485:2016 certified internal auditor status is an advantage