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Senior Supplier Quality Engineer

Olympus Corporation · District de Tel Aviv

Senior 🇬🇧 English
APQP FAI Process Validation IQ/OQ/PQ 8D 5 Whys FMEA Root Cause Analysis ISO 9001 FDA QSR GMP MDSAP Supplier Qualification

תיאור המשרה

About the role

We are looking for a Senior Supplier Quality Engineer to lead supplier quality initiatives for our medical device portfolio. You will act as the primary quality liaison with suppliers, ensuring that quality requirements are embedded from concept through launch and that regulatory standards are consistently met.

Key responsibilities

  • Develop and implement supplier quality strategies, including incoming inspection and quality planning.
  • Represent Supplier Quality on new product development projects.
  • Lead supplier qualification activities such as APQP, FAI, process validation and early supplier involvement.
  • Own non‑conformance management, SCARs, root‑cause analysis and corrective actions.
  • Drive continuous improvement and monitor supplier performance through metrics.
  • Manage supplier‑related engineering changes, material qualifications and technical risks.
  • Define incoming inspection plans and act as the primary quality contact for suppliers.
  • Support internal, supplier and regulatory audits (FDA, ISO, MDSAP).

Required profile

  • Bachelor’s degree in Life Sciences, Engineering, Physical Sciences or a related technical discipline.
  • Minimum 5 years of Supplier Quality Engineering experience in a highly regulated industry (medical devices, IVD, etc.).
  • Strong knowledge of global quality and regulatory requirements (ISO 9001, FDA QSR, GMP).
  • Excellent communication, stakeholder management and project‑management skills.
  • Professional fluency in English and willingness to travel internationally (~20%).

Required skills

  • APQP, FAI, Process Validation, IQ/OQ/PQ.
  • Quality tools: 8D, 5 Whys, FMEA, Root‑Cause Analysis, Corrective‑Action Management.
  • Regulatory standards: ISO 9001, FDA QSR, GMP, MDSAP.
  • Supplier qualification, performance monitoring and metrics.
  • Audit support and non‑conformance management.

What we offer

  • Competitive salary and a locally competitive benefits package for employees based in Israel.
  • Benefits that support wellbeing, professional development and work‑life balance.
  • Opportunities to work on innovative medical device projects with global impact.

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Olympus Corporation

District de Tel Aviv