Job description

An International Medical Device company Located in Yokneam (North Israel) is looking for a NPD Quality & Compliance Engineer


  • Support R&D Design activities throughout the Product Development process
  • Managing Project DHF and providing status to the Project management
  • Provide quality inputs for new or modified products development
  • Accountable for the Product Risk Management process throughout the PDP
  • Support the Design Change process by reviewing the change and performing impact assessments with the team
  • Participate and approve the Product Design Reviews
  • Review and approval of the Product DHF documents
  • Write, review, and implement quality procedures
  • Verify the product complies with applicable standards
  • Lead quality improvements for product and processes
  • Support Internal and External Audits

Experience and Education:

  • Bachelor’s Degree in engineering or equivalent – Required
  • At least 3 years of experience in the Medical Device industry – Required
  • Knowledge of medical devices standards and regulation (EU MDD/ MDR, CFR 820, ISO13845, ISO14971 etc.) – Required
  • Critical thinking and investigation skills – Required
  • Experience in Medical Device NPD/NPI – Advantage
  • CQE/ ICQE – Advantage
  • Demonstrated scientific analysis abilities – Major Advantage
  • Internal/lead auditing certificate – Advantage
  • Familiar with general QMS concepts, including GDP, CAPA, and document change control practices
  • Strong written and verbal communication skills in English
  • Ability to multitask
  • Developed presentation skills
  • Excellent interpersonal skills

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