Senior Quality Engineer

Stryker · Grecia, Costa Rica · full time · On site · July 01, 2026

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Posted July 01, 2026 · Read from Stryker
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Work Flexibility: Onsite

What You Will Do

  • Lead investigations of non-conformances and implement corrective and preventive actions to support timely issue resolution.
  • Collaborate with Engineering, Production, and cross-functional teams to ensure products and processes meet quality requirements.
  • Support internal and external audits by preparing documentation, participating in audit activities, and addressing audit observations.
  • Escalate quality concerns to Quality Assurance and Engineering leadership and support resolution activities.
  • Manage containment activities for non-conforming product, including identification, segregation, documentation, and reconciliation.
  • Monitor, analyze, and trend quality data to identify risks, recurring issues, and improvement opportunities.
  • Ensure compliance with the Quality Management System and applicable regulatory requirements.
  • Apply statistical analysis and risk management tools, including Failure Mode and Effects Analysis (FMEA), to support decision-making and continuous improvement initiatives.

Required Qualifications

  • Bachelor’s degree in Engineering or a related technical field.
  • Minimum 3 years of experience in Quality Engineering.
  • Working knowledge of 21 CFR Part 820, ISO 13485, and the Medical Device Single Audit Program (MDSAP).
  • Advanced English proficiency, written and verbal.

Preferred Qualifications

  • Experience supporting internal and external quality audits.
  • Experience conducting investigations, risk assessments, and corrective and preventive action activities.
  • Experience working in a regulated manufacturing environment.
  • Experience using statistical analysis and quality risk management tools.

Travel Percentage: None

Employer
Stryker
Location
Grecia, Costa Rica · On site
Contract
full time