Senior Supplier Quality Engineer - Medical Devices

Gentherm; Celaya; On-site; MXN 600,000 - 900,000; Full time

Job summary

Stryker is seeking a Senior Supplier Quality Engineer to strengthen the supplier network and ensure regulatory compliance across external manufacturers. You will collaborate with OEMs, contract manufacturers, and internal teams to address quality issues and drive improvements.

You will lead audits, monitor KPIs, and guide continuous improvement initiatives with external partners, maintaining high standards for medical device quality across the supplier base.

Qualifications

• Bachelor's degree in Engineering is required.
• Minimum 5 years of experience in Quality Engineering, Supplier Quality, Manufacturing Quality, or related quality function.
• Professional working proficiency in English.
• Experience with quality systems, supplier quality, manufacturing processes, or regulatory compliance.

Responsibilities

• Manage supplier quality issues across assigned external manufacturers, ensuring material quality concerns are documented, communicated, investigated, and addressed.
• Coordinate Material Review Board activities with business units to support timely assessment and disposition of potentially nonconforming products.
• Serve as the Supplier Quality point of contact during internal and external audits and coordinate required follow-up activities.
• Ensure supplier compliance with applicable medical device regulations, Good Manufacturing Practices, and Stryker quality requirements.
• Partner with Manufacturing, Quality, Procurement, Strategic Sourcing, and business units to assess and resolve supplier and material quality issues.
• Track supplier quality key performance indicators, report metrics during monthly business reviews, and participate in supplier performance evaluations.
• Oversee supplier quality documentation and the Approved Supplier List in partnership with Procurement.
• Drive continuous improvement activities with external manufacturing partners and provide technical guidance related to supplier quality systems and regulatory requirements.

Skills

Quality Engineering

Supplier Quality

Regulatory Compliance

English proficiency

Education

Bachelor's degree in Engineering

Job description

Stryker is seeking a Senior Supplier Quality Engineer to strengthen the supplier network and ensure regulatory compliance across external manufacturers. You will collaborate with OEMs, contract manufacturers, and internal teams to address quality issues and drive improvements.

You will lead audits, monitor KPIs, and guide continuous improvement initiatives with external partners, maintaining high standards for medical device quality across the supplier base.