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