Quality Engineers

Maintain and improve the Quality Management System (QMS) as per ISO 13485 and regulatory requirements.

Handle CAPA, non-conformance investigations, root cause analysis, and corrective actions.

Support internal/external audits and ensure timely closure of audit observations.

Review quality documents, SOPs, validation protocols, and manufacturing records.

Conduct in-process quality checks and monitor product quality.

Participate in risk management, change control, and supplier quality activities.

Analyze quality data and implement process improvement initiatives.

Requirements

Bachelor's degree in Engineering (Mechanical, Biomedical, Electronics, or related field).

2-3 years of experience in medical device manufacturing quality.

Knowledge of ISO 13485, GMP, CAPA, NCR, and validation processes.

Strong problem-solving, analytical, and documentation skills.