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

See also