NPD Quality Engineer Class III

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
  
  

• 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.