Quality Engineer

StrykerSalt Lake City, UT
20hOnsite

About The Position

Stryker is hiring a Quality Engineer to support our Neurovascular division in Salt Lake City, Utah. This is an onsite role requiring in-office presence 5 days per week. As Quality Engineer, you will champion quality and lean methodologies, drive process improvements, and ensure compliance to deliver superior products to patients and customers.

Requirements

  • Bachelor of Science in Engineering or related discipline
  • 0+ years of related experience

Nice To Haves

  • Experience working in a multi-site team environment
  • Understanding of medical device concepts
  • Knowledge of engineering and quality principles
  • Familiarity with ISO 13485, GDP, GMP standards
  • Understanding of risk-based and statistical concepts

Responsibilities

  • Partner with operations and business functions to ensure product and process quality performance.
  • Initiate and manage Non-Conformances (NC) and Corrective and Preventive Actions (CAPA), including root cause analysis and problem-solving.
  • Support development and improvement of manufacturing processes for new and existing products.
  • Review and execute change management activities.
  • Monitor KPIs for process and supplier quality, analyze trends, and implement corrective actions.
  • Support Quality Assurance Testing (QAT) execution and analysis.
  • Apply risk management practices and optimize inspection methods, including First Article Inspections.
  • Utilize statistical methods and interpret manufacturing prints and tolerances to ensure compliance.
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