Added
6 days ago
Type
Full time
Salary
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Related skills

data analysis iso gmp root cause analysis risk assessment

📋 Description

  • Own quality projects and investigations within the Endoluminal product platform across design
  • Escalation owner for low to medium impact quality risks.
  • Review and maintain test records and reports for completeness and accuracy.
  • Drive CAPA and systemic non-conformances and contribute to QMS updates.
  • Lead risk assessments and process reviews; analyze defect trends and report findings.
  • Ensure compliance with GMP, ISO, and FDA standards; collaborate with project Core Teams.

🎯 Requirements

  • Minimum 5 years of QE/QA experience; bachelor’s degree in engineering or related field (or
  • Solid quality principles and methodologies; strong data analysis and interpretation.
  • Ability to identify and resolve quality issues independently; strong communication and teamwork.
  • Stay updated with evolving standards, tools, and technologies.
  • Willingness to travel <10% and perform frequent computer and inspection work; occasional lifting

🎁 Benefits

  • Equal Opportunity Employer; committed to fair employment practices.
  • Vaccination or other regulatory requirements may apply depending on role and location.
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