Stryker
Publicado
abril 17, 2025
Ubicación
Tijuana, Tijuana, Mexico
Tipo de empleo

Descripción

What you will do

As an OEM (Original Equipment Manufacturer) / CM (Contract Manufacturer) Quality Engineer at Stryker, you will partner with the Global Supplier Network to support New Business Integration projects, ensuring supplier quality, regulatory compliance, and continuous improvement across external manufacturing partners. You will act as a liaison between internal teams and OEM/CMs, driving alignment in quality expectations and performance.

Main responsabilities:

  • Own OEM/CM quality performance metrics (KPIs) and support supplier performance reviews for finished goods
  • Serve as quality liaison between Stryker divisions and OEM/CMs, resolving compliance issues
  • Support internal and external audits, ensuring regulatory compliance (FDA, IMB, Notified Bodies, etc.)
  • Participate in MRB processes, assessing non-conforming materials with relevant business units
  • Maintain structured communication with strategic sourcing and quality teams
  • Assist with maintenance of the Approved Supplier List (ASL) and onboarding of new finished goods suppliers
  • Support NPI, site integration, product transfers, and M&A projects to ensure QMS compliance
  • Participate in supplier audits and support the development of Quality Assurance Agreements

What you need

  • Bachelor’s degree in engineering, science fields or equivalent.
  • 2 to 5 years’ experience in a Manufacturing environment required.
  • Previous experience as Quality Engineer required.
  • Fluent in written & oral English required.
  • Basic Knowledge in statistics.
  • Good communication skills and ability to obtain desired outcome is desired.
  • Good understanding and ability to work with Microsoft Office.
  • Basic knowledge with GMP, ISO 13485, 21 CFR Part 820 standards.
  • Basic knowledge of FMEA, Validation Programs and SPC processes in a highly regulated environment desirable.
  • Good knowledge of continuous improvement methodologies.
  • Willing to travel in support of business needs to different geographical locations.

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