Quality Engineer

Responsibilities

• Maintain and improve the Quality Management System (QMS) in accordance with ISO 13485 and/or FDA 21 CFR 820.
• Prepare, review, and update procedures, work instructions, and quality records.
• Ensure compliance with GMP and good documentation practices.
• Develop and validate inspection methods, testing procedures, and acceptance criteria.
• Coordinate inspection activities for raw materials, in-process, and finished goods.
• Lead investigations of nonconformities (NCR), CAPA, deviations, and customer complaints.
• Follow up on corrective and preventive actions.
• Participate in continuous improvement projects (Lean, Six Sigma).
• Participate in process, equipment, and production line validations (IQ, OQ, PQ).
• Support new product introduction and transfer to manufacturing.

Qualifications

• Bachelor’s degree in Biomedical Engineering, Industrial ...