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Join our team
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Join Our Team

NPD Quality & Compliance Engineer

Description

• 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

Requirements

• 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

Location: יקנעם

Comments

Biosense Webster is an equal opportunity employer promoting diversity and inclusion in the work place.
This position may be suitable for any person subject to their qualifications and capabilities, regardless of (inter alia) gender, origin, ethnicity, sexual orientation, and/or disability.