Senior Quality Engineer (Open) (Remote)

Stryker; Tijuana; Hybrid; MXN 900.000 - 1.300.000; Vollzeit

Zusammenfassung

Stryker is seeking a Senior Supplier Quality Engineer to oversee quality across external manufacturers and supplier networks. You will collaborate with OEMs, contract manufacturers, and internal teams to address issues, monitor performance, and ensure regulatory compliance.

You will lead MRB activities, support audits, and drive continuous improvement in supplier quality systems. English proficiency and a strong background in quality engineering are essential.

Qualifikationen

• Bachelor’s degree in Engineering or related technical field.
• 5+ years in Quality Engineering, Supplier Quality, Manufacturing Quality, or related function.
• Professional working proficiency in English.
• Experience with quality systems, supplier quality, manufacturing processes, or regulatory compliance.
• Preferred: experience in medical device or regulated manufacturing environments.
• Preferred: experience with external/contract manufacturers and GMP/supplier audits.

Aufgaben

• 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 for timely assessment and disposition of potentially nonconforming products.
• Serve as the Supplier Quality point of 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, and Strategic Sourcing to address supplier and material quality issues.
• Track supplier quality KPIs, report metrics during monthly reviews, and participate in supplier evaluations.
• Oversee supplier quality documentation and the Approved Supplier List with Procurement.
• Drive continuous improvement with external manufacturing partners and provide guidance on supplier quality systems and regulatory requirements.

Kenntnisse

Quality Engineering

Supplier Quality

Regulatory Compliance

Ausbildung

Bachelor’s degree in Engineering

Jobbeschreibung

Work Flexibility: Hybrid 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.

Travel Percentage: 20%

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com

Work Flexibility Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location.

Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based.

Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category.

Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.