Senior Quality Engineer (Remote)

Stryker; Tijuana; Remote; MXN 850,000 - 1,150,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Quality engineering

English proficiency

Education

Bachelor’s degree in Engineering or related technical field

Job description

Join Stryker as a Senior Supplier Quality Engineer, supporting quality performance across our external manufacturing and supplier network. You will work closely with Original Equipment Manufacturers and Contract Manufacturers, as well as Stryker’s Quality, Manufacturing, Procurement, and Strategic Sourcing teams, to address supplier quality issues, monitor performance, maintain regulatory compliance, and support continuous improvement.

What you will do

• 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.

What you will need

Required

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

Preferred

• Experience within the medical device or another regulated manufacturing industry.
• Experience supporting external manufacturers, contract manufacturers, or supplier quality activities.
• Experience with Good Manufacturing Practices, supplier audits, nonconforming product management, and continuous improvement.