Senior Quality Engineer, Global Capability Centre

What you will do:

The Senior Quality Engineer works with the Global Supplier Network to resolve quality issues, support supplier development, and ensure supply chain performance meets quality, service, and cost expectations. Collaborating with internal teams and suppliers, you’ll address quality concerns and provide technical support while ensuring suppliers meet product quality, regulatory standards, and Stryker requirements. 

Responsibilities:

• Act as liaison for customer groups on compliance issues.
• Provides leadership to the OEM/CM Team, overseeing plant metrics and quality procedures. 
• Own and report on quality issues related to OEM/CM suppliers within the assigned commodity.
• Communicate material quality issues with suppliers effectively.
• Oversee OEM/CM material processes, including MRB coordination and timely assessment of non-conforming products.
• Serve as point of contact for OEM/CM Quality during audits.
• Ensure regulatory compliance with GMP and medical regulatory agencies (e.g. FDA, IMB).Develop communication channels with strategic sourcing and liaise with manufacturing, quality, and business units.
• Track supplier performance and represent the OEM/CM quality team in monthly business reviews.
• Oversee the Approved Supplier List (ASL) with Procurement.
• Drive continuous improvement in OEM/CM quality.

What you need: 

• Bachelor’s degree in a Science, Engineering or related discipline preferred.
• 3+ years of experience in in a manufacturing environment.
• Fluency in English essential.

Preferred Qualifications:

• Knowledge of GMP, ISO 13485, 21 CFR Part 820 standards.
• Working knowledge of FMEA, Validation Programs, and SPC processes in a highly regulated environment.
• Proficiency in lean tools and concepts, with demonstrated ability to apply them to improve quality.
• Strong analytical, problem-solving, and data-driven decision-making skills. 
• Excellent planning, organization, and multi-tasking abilities.
• Strong communication skills with the ability to communicate effectively across all levels of the organization.