Quality Engineer

We are seeking a Process Quality Engineer with experience in the medical device industry to ensure regulatory compliance and process stability within controlled manufacturing environments.

Key Responsibilities:

• Ensure compliance with applicable regulations such as ISO 13485 and FDA requirements.
• Maintain and continuously improve the Quality Management System (QMS) related to manufacturing processes.
• Develop and monitor process controls, including statistical analysis (SPC) and variation reduction initiatives.
• Lead investigations of process-related nonconformities and drive corrective and preventive actions (CAPA).
• Support process validations (IQ, OQ, PQ) and revalidations.
• Conduct risk analysis (PFMEA) and develop control plans.
• Provide support during internal, customer, and regulatory audits.
• Ensure compliance with cleanroom procedures and controlled environment standards.