Global Quality QMS Leader - FDA/ISO Compliance

Celestica Inc.; Monterrey; Presencial; MXN 900.000 - 1.300.000; Jornada completa

Descripción de la vacante

Celestica is seeking a Senior Quality QMS Manager to lead global quality management activities and harmonize processes across sites. You will drive regulatory readiness, CAPA, and supplier quality programs while partnering with leadership to ensure compliance with ISO 13485 and FDA requirements.

Travel up to 50% is expected; a Bachelor's degree in engineering, life sciences, or quality management is required, with 7–10 years in medical device quality and prior multinational experience preferred.

Formación

• Minimum 7-10 years in quality assurance/QMS in the medical device industry.
• Experience with ISO 13485; participation in FDA inspections.
• Global or multi-site managerial experience preferred.
• Strong risk management and regulatory audit history.

Responsabilidades

• Lead global QMS harmonization and regulatory audits (FDA/notified bodies).
• Drive CAPA, non-conformances, and training programs.
• Oversee internal audits and inspection readiness.
• Improve quality agreements and supplier quality processes.

Conocimientos

Leadership

Cross-functional collaboration

Regulatory knowledge

Quality management

Communication skills

Educación

Bachelor's degree in Engineering/Life Sciences/Quality Management

Descripción del empleo

Celestica is seeking a Senior Quality QMS Manager to lead global quality management activities and harmonize processes across sites. You will drive regulatory readiness, CAPA, and supplier quality programs while partnering with leadership to ensure compliance with ISO 13485 and FDA requirements.

Travel up to 50% is expected; a Bachelor's degree in engineering, life sciences, or quality management is required, with 7–10 years in medical device quality and prior multinational experience preferred.