Quality Engineer

Performs independent technical assessment on product quality performance across medical device design and manufacturing phases.

Apply Six Sigma Green Belt techniques and analytical frameworks to evaluate Product Quality and process reliability.

Ensure strict regulatory adherence to ISO 13485 (Medical Devices Quality Management Systems) and CQA (Certified Quality Auditor) standards.

Collaborate with R&D teams to verify Software Design integration, code reliability, and software quality assurance for healthcare equipment.

Conduct comprehensive risk management, technical audits, and design history file (DHF) reviews within the Healthcare sector.

Partner cross-functionally to manage non-conformance tracking, regulatory reporting, and supplier quality evaluations.

Maintain complete, audit-ready compliance documentation and technical verification archives.

Bachelor's or Master's degree in Engineering (Biomedical, Mechanical, Electrical, Computer Science) or related scientific fields.

0-1 Yrs of extensive experience in quality engineering, medical devices, or high-reliability software/hardware environments.

Specialized expertise in ISO 13485, Six Sigma (Green Belt), CQA frameworks, and medical software/hardware quality assurance.

Exceptional analytical capability, technical auditing skills, and cross-functional leadership skills.