Risk Management Quality 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 a Risk Management Quality Engineer role, to join our team located in Yokneam, Israel.

You will be responsible for:

Responsible for assuring compliance with product Risk Management Policies and Standards

Accountable for execution of the Risk Management process throughout the product lifecycle from product development early stages till post-market (PMS reports) – across all projects

Responsible for managing risk evaluation for Escalations or DRB meetings per request

Manage product Risk Management File (including change control process, risk assessment, and approval of V&V-related deliverables)

Coordinates the Risk Management Team – across all projects

Provide inputs and collaborate with various local and global teams: Medical Safety, Medical Affairs, R&D, SQA, RA, Operations, Complaints, Service and PMS teams

Support for Internal and External audits

Perform training on Risk Management for internal and external teams

Participate in improvement activities: process and product

Qualifications and Requirements:

BA degree – required, preferable - BSc in engineering science / ME / BA in Quality or Statistics or equivalent field

CQE/ ICQE certificate, Internal auditing certificate – Advantage

At least 3 years of experience in the Medical Device industry - Required

Knowledge of the methods, processes, and techniques used for planning, developing, implementing, directing, coordination and evaluation of Quality Assurance Risk Management

Knowledge of medical devices standards (ISO13845, ISO14791 etc.) – Required

Experience in Six Sigma methodology, experience in statistical methods implementation during product design - Advantage

Excellent written and spoken English

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