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Quality

NPD Quality Engineer Class III

  • Job Title NPD Quality Engineer Class III
  • Function Quality
  • Sub Function Quality Assurance
  • Location Yokneam, Northern, Israel
  • Date Posted
  • Requisition Number 2406165507W
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Description

We at Biosense are looking for a NPD Quality & Compliance Engineer for an innovative new project.  In this role you will: 


• Lead R&D Design activities throughout New Product Introduction & during 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 internal and external standards
• Drive continues improvements in product quality and manufacturing processes, working with and R&D &  CM to identify and resolve quality gaps

• Act as a primary contact for escalating manufacturing & quality issues identified by CM.

• Lead and contact Root Cause analysis and develop reports on manufacturing defects from customer feedback & internal findings according to internal QMS

• Support Internal and External Audits

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Qualifications

• Bachelor's Degree in engineering or equivalent – Required
• At least 3 years of experience in the Medical Device industry, specific in NPD/NPI – Required
• Knowledge of medical devices standards and regulation (EU MDD/ MDR, CFR 820, ISO13845,  ISO14971 etc.) – Required
• Critical thinking and investigation skills – Required 

•Effective communication & collaboration skills to cooperate with Design Engineers, manufacturing teams and other stakeholders
• 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 

• Strong documentation skills for review quality documents and Quality records. 

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