Quality Engineer

·       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.