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.
Qualifications:
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, 8 D, SPC, MSA).
Experience in process validation and technical documentation.
Advanced English (required).
Strong analytical skills, attention to detail, and continuous improvement mindset.

📌 Quality engineer (Chihuahua)
🏢 Grupo TECMA
📍 Chihuahua