Senior Quality Engineer

Stryker Group; Tijuana; Presencial; MXN 1,099,000 - 1,466,000; Jornada completa

Descripción de la vacante

A leading medical device company in Tijuana is seeking an experienced Supplier Quality Manager to collaborate with OEM and CM suppliers. The role includes ensuring compliance with regulatory standards, driving continuous improvement initiatives, and managing supplier quality systems. The ideal candidate will hold a Bachelor's degree in Engineering and have significant experience in supplier quality management or supply chain in regulated industries.

Formación

• Experience with supplier quality management or supply chain in a regulated industry.
• Knowledge of regulatory standards (e.g., FDA, ISO 13485, GMP).

Responsabilidades

• Serve as the main liaison between the company and OEM/CM suppliers.
• Ensure compliance with regulatory standards and manage non-conforming products.
• Drive continuous improvement activities in supplier quality.

Conocimientos

Supplier quality management

Regulatory standards knowledge

Continuous improvement techniques

Educación

Bachelor’s degree in Engineering or related field

Descripción del empleo

What you will do

In this role, you will partner with the Global Supplier Network and Finish Goods Operations (FGO) to ensure our external supply chain consistently meets Stryker’s high standards for quality, service, and cost. Acting as a liaison between Stryker and its OEM (Original Equipment Manufacturer) and CM (Contract Manufacturer) suppliers, you will support supplier quality systems, drive continuous improvement initiatives, and collaborate with cross-functional teams to guarantee compliance with regulatory requirements and company standards.

Key Responsibilities

• Serve as the main liaison between Stryker and OEM/CM suppliers, driving effective continuous improvement initiatives.
• Provide technical support for supplier quality system assessments and performance evaluations.
• Ensure clear ownership, reporting, and communication of all supplier-related material quality issues within assigned commodities.
• Oversee OEM/CM material-related processes, including Material Review Board (MRB) activities, ensuring timely resolution of non-conforming products.
• Act as the point of contact for OEM/CM quality during external (e.g., FDA, Notified Bodies) and internal audits.
• Track and report OEM/CM performance metrics (KPIs), enabling regular reviews and contributing to Monthly Business Reviews.
• Manage and maintain the Approved Supplier List (ASL) in collaboration with the Procurement team.
• Drive continuous improvement activities in supplier quality, in close partnership with Finish Goods Operations, Manufacturing, Quality, and Business Units.

What you need

Required:

• Bachelor’s degree in Engineering, Quality, or related technical field.
• Experience with supplier quality management or supply chain in a regulated industry.
• Knowledge of regulatory standards (e.g., FDA, ISO 13485, GMP).

Desired:

• Experience working directly with OEM/CM suppliers in the medical device or similar regulated sector.
• ASQ Certification (e.g., CQE, CQA, CSSGB) or equivalent.
• Experience with auditing suppliers and managing Approved Supplier Lists.
• Lean/Six Sigma or continuous improvement project experience.