Global Quality & QMS Lead — Medical Devices

Celestica; Monterrey; Híbrido; MXN 600.000 - 900.000; Jornada completa

Descripción de la vacante

Celestica is seeking a Quality QMS Manager in Monterrey, Mexico. You will lead global QMS harmonization, drive CAPA processes, and oversee audits and regulatory inspections (FDA/Notified Bodies).

The role requires travel and strong collaboration with global teams to ensure compliance across sites. The ideal candidate has 7–10 years in medical device QA/QMS, ISO 13485 knowledge, and experience with regulatory inspections, with a Bachelor’s in engineering or life sciences and an advanced degree

Formación

• Bachelor's degree in Engineering, Life Sciences, Quality Management, or a related technical discipline.
• An advanced degree (Master's or MBA) is preferred.
• Minimum 7-10 years in quality assurance/QMS in medical device industry.
• Experience with ISO 13485 and FDA inspections.

Responsabilidades

• Lead global harmonization of QMS to ensure compliance across sites.
• Manage CAPA system and lifecycle of controlled documentation.
• Oversee internal audits and FDA inspections; support regulatory readiness.
• Develop and deliver global QMS training and onboarding for HT employees.

Conocimientos

ISO 13485

FDA 21 CFR Part 820

Device Regulations

Leadership

Cross-functional collaboration

Analytical thinking

Risk management

Documentation

Communication

Educación

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

Advanced degree (MBA or MSc) preferred

Descripción del empleo

Celestica is seeking a Quality QMS Manager in Monterrey, Mexico. You will lead global QMS harmonization, drive CAPA processes, and oversee audits and regulatory inspections (FDA/Notified Bodies).

The role requires travel and strong collaboration with global teams to ensure compliance across sites. The ideal candidate has 7–10 years in medical device QA/QMS, ISO 13485 knowledge, and experience with regulatory inspections, with a Bachelor’s in engineering or life sciences and an advanced degree