Senior Quality Engineer - Endoluminal Systems

Added
16 hours ago
Type
Full time
Salary
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Related skills

data analysis iso audits gmp npi

๐Ÿ“‹ Description

  • Oversee end-to-end quality investigations across manufacturing, supplier ops, design, and customer
  • Lead cross-functional and cross-site quality investigations and audits.
  • Own CAPA, Process NCs, risk assessments, and regulatory/compliance activities.
  • Support regulatory and customer audits; interpret advanced quality data and KPI trends.
  • Mentor junior engineers; ensure compliance with GMP, ISO, FDA standards.

๐ŸŽฏ Requirements

  • Minimum 8 years QE/QA experience; engineering degree or equivalent.
  • 2+ years in a regulated industry; experience supporting NPI and mechanical assembly of
  • Strong data analysis, issue resolution, and cross-team collaboration.
  • Experience with GMP, ISO, FDA; ability to lead quality improvements and risk assessments.
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