Risk Management Quality Engineer

10 hours ago

Yokneam Haifa District Israel Johnson & Johnson Full time ₪120,000 - ₪180,000 per year

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

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 

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

#LI-LM5#LI-Hybrid

#Electrophysiology

Required Skills:

Preferred Skills:

Agility Jumps, Business Behavior, Compliance Management, Continuous Improvement, Database Backup, Data Gathering Analysis, Data Savvy, Disruptive Innovations, Execution Focus, Issue Escalation, Process Oriented, Product Improvements, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Report Writing

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