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Quality Engineer

  • Location


  • Salary

    US$85000 - US$120000 per year

  • Sector


  • Job Ref


  • Contact

    Amanda Russo

  • Published

    etwa 1 Monat her

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I am working with a client that is a leader in medical device design and manufacturing, looking for a Quality Engineer to join their team. This candidate will collaborate within cross-functional teams and uphold impeccable quality systems and regulatory standards throughout each project's lifecycle. This is an on-site position. If interested please apply with a most recent copy of your resume.

Key Responsibilities:

  • Maintain ISO 13485 and FDA QSR Compliant Quality Management System.
  • Evaluate material biocompatibility and sterilization methods.
  • Design and execute product/process documentation, including inspection plans.
  • Conduct feasibility studies to ensure design functionality.


  • Bachelor's degree in a scientific/engineering discipline or AA/AS degree with relevant experience.
  • 0-2 years' recent medical device industry exposure, preferably in catheter-based/disposables. Cardiovascular experience is a plus.
  • Familiarity with FDA medical device Quality Systems Regulations and international quality system standards (QSR/ISO 13485).
  • Ability to engage professionally with client companies.
  • A blend of passion, persistence, resourcefulness, and an entrepreneurial spark.

Core Competencies:

  • Communicate technically and professionally in verbal and written formats.
  • Efficiently manage resources and prioritize tasks.
  • Exceed customer expectations with prompt, reliable, and professional service.
  • Listen actively and diplomatically resolve discrepancies.
  • Demonstrate initiative, creativity, and organization