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Open nowFirst seen 2 days ago

Quality Engineer - Design Control

megoafek/7a.0036 open roles

Where
Mego Afek AC Ltd.
Work mode
On site
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Your applicationOpen nowQuality Engineer - Design Controlmegoafek/7a.003 · Mego Afek AC Ltd.

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11.8% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 2.1%1 day
  2. 4.4%3 days
  3. 11.8%7 days
  4. 18.6%14 days
  5. 35.6%30 days
  6. 45.1%60 days
This job: first seen 2 days ago

The posting

  • The Quality Engineer will provide quality oversight for new product development, sustaining engineering changes, risk management activities, and maintenance of Design History File (DHF) documentation while ensuring compliance with applicable regulations and standards.
  • Ensure compliance with Design Control requirements and internal procedures.
  • Review and monitor of design planning, design reviews, design V&V, and design transfer activities for compliance.
  • Ensure traceability between user requirements, design inputs, design outputs, risk controls, V&V activities.
  • Review and approve ECOs, ECRs for risk, and compliance with QMS and standards.
  • Verify that changes are properly documented, approved, implemented, and closed according to established procedures.

Requirements

  • Bachelor's degree in Engineering, Biomedical Engineering, Mechanical Engineering, Quality Engineering, or related technical/medical discipline.
  • Certified Quality Engineer (CQE) or equivalent certification – advantage
  • At least 5 years of Quality Engineering experience in the medical device industry.
  • Experience with relevant standards (ISO13485, ISO 14971).
  • Experience supporting Design Control and Change Control processes.
  • Experience reviewing DHF, DMR, V&V protocols and reports, and other technical documentation.
  • Fluent English (written and spoken).
  • Proficiency in MS-OFFICE
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