Staff Quality Engineer

Stryker • Arlington, TN

18h • Onsite

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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.

Responsibilities

• 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 This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees