Quality Engineer

Grupo TECMA; Ciudad Juárez; Presencial; MXN 334.800 - 558.000; Jornada completa

Descripción de la vacante

A leading company in the medical device sector in Ciudad Juárez is seeking a Process Quality Engineer to ensure regulatory compliance and process stability in controlled manufacturing environments. The ideal candidate will hold a Bachelor's degree in Engineering and possess at least 3 years of experience in the medical device industry, with strong knowledge of ISO 13485 and quality tools. This role requires advanced English skills and a detail-oriented mindset. Benefits include opportunities for career growth within a quality-focused team.

Formación

• 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 quality tools (PFMEA, 8D, SPC, MSA).
• Experience in process validation and technical documentation.

Responsabilidades

• Ensure compliance with ISO 13485 and FDA requirements.
• Maintain and improve the Quality Management System (QMS).
• Develop and monitor process controls including statistical analysis.
• Lead investigations of process-related nonconformities.
• Support process validations (IQ, OQ, PQ) and revalidations.
• Conduct risk analysis (PFMEA) and develop control plans.
• Ensure compliance with cleanroom procedures.

Conocimientos

ISO 13485

Statistical Process Control (SPC)

Process validation

Risk analysis (PFMEA)

Analytical skills

Attention to detail

Continuous improvement mindset

Advanced English

Educación

Bachelor's degree in Engineering

Descripción del empleo

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