NPD Quality & Compliance Engineer

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Quality

Job Sub Function:
R&D/Scientific Quality

Job Category:
Professional

All Job Posting Locations:
Yokneam, Haifa District, Israel

Job Description:

About Johnson & Johnson MedTech Cardiovascular:

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke.

You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.

Your unique talents will help patients on their journey to wellness.

Learn more at https://www.jnj.com/medtech

We are searching for the best talent for an NPD Quality & Compliance Engineer  role, to join our team located in Yokneam, Israel.

You will be responsible for:


* 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

Qualifications and 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...