Senior Engineer, Advanced Quality (Onsite)
Work Flexibility: Hybrid or Onsite
Stryker is hiring a Senior Engineer, Advanced Quality for our Instruments (Neurosurgical) division. This is an onsite role based in Portage, MI.
As the Senior Engineer, Advanced Quality you will support quality engineering throughout new product development. In this role, you will lead design quality activities across risk management, reliability engineering, human factors, design verification and validation, and process validation while partnering with Engineering, Manufacturing, and Product Development teams to ensure products meet applicable quality and regulatory requirements.
What You Will Do
- Lead quality engineering activities for new product development, ensuring compliance with FDA Quality System requirements, ISO 13485, and internal quality standards.
- Lead product risk management activities, including risk analysis, failure mode evaluation, risk mitigation, and assessment of product reliability.
- Apply quality engineering tools and statistical methods to evaluate components, assemblies, processes, and finished products throughout design and development.
- Lead human factors engineering and design validation activities to verify products meet defined user needs, intended uses,...
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