Senior Supplier Quality Engineer - Med Devices & Compliance

Stryker; Tijuana; A distancia; MXN 850.000 - 1.150.000; Jornada completa

Descripción de la vacante

Stryker is seeking a Senior Supplier Quality Engineer to oversee supplier quality performance across external manufacturers, including OEMs and CMOs, in Mexico. You will partner with Quality, Manufacturing, Procurement, and Strategic Sourcing to address issues and maintain regulatory compliance.

You will lead MRB activities, audits, supplier qualification, KPIs, and continuous improvement with external partners, ensuring GMP and medical device standards are met.

Formación

• Bachelor’s degree in Engineering or a related technical field.
• Minimum 5 years of experience in Quality Engineering or supplier quality.
• Professional working proficiency in English.
• Experience with quality systems, regulatory compliance, and GMP.

Responsabilidades

• Manage supplier quality issues across external manufacturers, ensuring documentation, communication, investigation, and corrective actions.
• Coordinate Material Review Board activities to assess and disposition nonconforming products.
• Serve as the Supplier Quality contact during audits and coordinate follow-up activities.
• Ensure supplier compliance with medical device regulations, GMP, and Stryker quality requirements.
• Partner with Manufacturing, Quality, Procurement, Strategic Sourcing, and business units to resolve supplier quality issues.
• Track supplier quality KPIs and report metrics during monthly reviews and supplier evaluations.
• Oversee supplier quality documentation and the Approved Supplier List with Procurement.
• Drive continuous improvement activities with external manufacturers and provide guidance on supplier quality systems and regulatory requirements.

Conocimientos

Quality engineering

English proficiency

Educación

Bachelor’s degree in Engineering or related technical field

Descripción del empleo

Stryker is seeking a Senior Supplier Quality Engineer to oversee supplier quality performance across external manufacturers, including OEMs and CMOs, in Mexico. You will partner with Quality, Manufacturing, Procurement, and Strategic Sourcing to address issues and maintain regulatory compliance.

You will lead MRB activities, audits, supplier qualification, KPIs, and continuous improvement with external partners, ensuring GMP and medical device standards are met.