Job Description


Job Summary:
  • Seeking a Quality Engineer with combined experience in supplier quality and manufacturing quality within the medical device industry.
  • The role will support supplier qualification, manufacturing process controls, and regulatory compliance to ensure product quality and continuous improvement in a regulated environment.
    • Responsibilities:
  • Manage supplier qualification, audits, and performance monitoring activities
  • Support manufacturing operations with quality oversight and issue resolution
  • Lead investigations, CAPA, SCAR, and nonconformance activities
  • Ensure compliance with FDA and ISO regulatory requirements
  • Participate in risk assessments and continuous improvement initiatives
  • Support internal and external audits and regulatory inspections
    • Education & Experience:
  • Bachelor's degree in Engineering or related field
  • + years of quality engineering ...

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