Job Description
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.