Quality Engineer
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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.
- Bachelor’s degree in Engineering (Industrial, Biomedical, Mechanical, or related field).
- Minimum 3 years of experience in process quality within the medical device industry.
- Experience working in cleanroom environments (ISO Class 7, 8, or equivalent).
- Strong knowledge of ISO 13485, and quality tools (PFMEA, 8D, SPC, MSA).
- Experience in process validation and technical documentation.
- Advanced English (required).
- Strong analytical skills, attention to detail, and continuous improvement mindset.
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