Operations Quality Engineer

19 hours ago


ModiinMaccabimReut Center District, Israel UR Tech Jobs Full time

Join our medical device team as an Operations Quality Engineer You'll be a key QA & RA representative, ensuring product quality and regulatory compliance throughout the manufacturing process, from design transfer to shipment. Drive continuous improvement, optimize processes, and champion quality on the production floor.

Responsibilities

  • Lead QA/RA activities in manufacturing, purchasing, and warehousing.
  • Maintain compliance with ISO 13485 and FDA regulations.
  • Review and approve operational documents (procedures, ECOs, etc.).
  • Facilitate Material Review Board (MRB) meetings.
  • Implement and monitor process controls (PV, EQ, pFMEA).
  • Support process validation activities (IQ/OQ/PQ).
  • Monitor KPIs, collect data, and report on operational performance.
  • Support CAPA investigations and external audits.
  • Manage supplier quality aspects (SCARs, audits).
  • Liaise between R&D and Operations for smooth transitions.

Qualifications

  • Bachelor's degree in science, engineering, or a related technical field, required.
  • Minimum 5 years of Operations Quality experience in the medical device industry.
  • Strong knowledge of ISO 13485 and FDA regulations.
  • Excellent English communication skills.
  • Proven ability to coordinate, prioritize, and resolve complex problems.
  • Experience with process validation, cleanroom controls, and supplier quality management.
  • Knowledge of Lean Manufacturing, 6S, and SPC.
  • CQE certification is a plus.
  • QualityEngineer #MedicalDevices #OperationsQuality #QAEngineer #RegulatoryCompliance #ISO13485 #FDACompliance #ProcessValidation #SupplierQuality #CAPA #LeanManufacturing #ContinuousImprovement #ManufacturingExcellence #Cleanroom #MRB #SCAR #pFMEA #CQE #QualityAssurance #QualityControl #EngineeringJobs #MedTechJobs


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