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Stryker Kalamazoo, MI, United States 2290 jobs openings

Staff Quality Engineer

Onsite Arlington, TX, United States Full Time Mid-Level Posted 20 days ago
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Job details

Staff Quality Engineer

Arlington, TN

This is a defined term assignment with an anticipated  start date of March, 2, 2026 and end date of March, 2, 2027.

As a Staff Quality Engineer at Stryker, you’ll play a critical role in ensuring our products meet the highest standards of safety and performance. You’ll lead quality initiatives, drive continuous improvement, and influence processes that directly impact patient outcomes worldwide. If you’re passionate about quality excellence and thrive in a dynamic environment, this is your opportunity to make a difference.

What You Will Do

  • Provide oversight and direction on product and process quality performance across operations and business functions.
  • Lead and execute quality initiatives and projects at local and global levels to improve compliance and efficiency.
  • Manage internal and supplier-driven non-conformances (NCs), ensuring timely investigation and closure.
  • Own and coach others through Corrective and Preventive Actions (CAPAs), driving root cause analysis to completion.
  • Interpret and act on KPI trends to implement continuous improvement strategies.
  • Serve as a recognized process owner in areas such as risk management, validation, inspection processes, and statistical sampling.
  • Participate in and lead internal and external audits, representing quality expertise and ensuring regulatory compliance.
  • Support manufacturing transfers and manage product holds or potential product escapes to maintain quality standards.

What You Will Need

Required Qualifications

  • Bachelor’s Degree in Engineering, Science, or a related field.
  • 4+ years of experience in a Quality or Regulatory Affairs role within a regulated industry.

Preferred Qualifications

  • Proficiency in medical device manufacturing processes and standards (ISO 13485, GMP).
  • Lean Six Sigma certification or training.
  • Experience interacting with regulatory agencies (e.g., FDA, MoH, TUV).
  • Advanced knowledge of risk management practices, CAPA, audits, and statistical techniques.
  • Familiarity with validation strategies and inspection optimization.


 

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.

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Staff Quality Engineer
Onsite Arlington, TX, United States Full Time Mid-Level Posted 20 days ago
Save Job