Quality Assurance Engineer- Maternity Leave

2 weeks ago

Haifa, Haifa, Israel Yael Korentec Technologies Full time ₪120,000 - ₪150,000 per year

A leading multi-disciplinary
medical device company
is seeking a
Quality Assurance Engineer

to join QA/RA team and support the product development lifecycle end-to-end, in compliance with international standards and regulatory requirements.

What you will do:

  • Lead
    Design Controls
    activities: planning, verification, validation, and design transfer – ensuring full documentation and end-to-end traceability.
  • Manage and maintain
    DHF – Design History File
    and ensure compliance with company QMS.
  • Conduct and support
    Risk Management
    activities according to ISO 14971: identification, assessment, controls, and monitoring.
  • Support design reviews (FDR/TDR) and engineering changes (ECO).
  • Participate in and/or lead
    internal and external audits
    , quality trainings, and Quality Management Reviews.
  • Work closely with
    R&D, Regulatory, Clinical, Process Development, and Manufacturing
    teams.

Requirements:

  • B.Sc. in Mechanical / Biomedical Engineering or related field from a recognized academic institution.
  • 3–5 years of experience
    as a Quality Engineer in a
    multi-disciplinary medical device company
    (hardware/software/mechanics).
  • Proven experience in
    Design Controls, requirements management, V&V, design changes, and design transfer
    .
  • In-depth knowledge of
    ISO 13485, ISO 14971, MDR, 21 CFR Part 820, IEC 62304, IEC 60601
    .
  • Experience working in a
    cross-functional / matrix environment
    (R&D/RA/Operations/Clinical).
  • Excellent English skills – reading, writing technical documents, and presenting.
  • Highly organized, detail-oriented, able to manage multiple tasks simultaneously, and strong interpersonal skills.

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