NPD Quality & Compliance Engineer

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

• 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
  
  

• 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