Quality Engineer

Job Description :

Seeking a Quality Engineer with experience in manufacturing processes, process validation, CAPA, and medical devices. Responsible for ensuring compliance with quality standards, supporting validation activities, and driving continuous improvement initiatives within a regulated environment.

Roles & Responsibilities :

• Support manufacturing process validation (IQ / OQ / PQ) to ensure compliance with regulatory standards.
• Lead and participate in CAPA investigations, root cause analysis, and implementation of corrective / preventive actions.
• Review and maintain documentation for validation protocols, reports, and quality records.
• Collaborate with cross-functional teams (Manufacturing, R&D, Quality) to resolve quality issues.
• Ensure compliance with FDA, ISO 13485, and GMP requirements for medical devices.
• Drive continuous improvement initiatives to enhance product quality and manufacturing efficiency.
• Support internal and external audits / inspections as required.