Risk Management Quality Engineer

Job Description

Biosense Webster R&D Haifa Technology Center (HTC) is located in Yokneam, Israel. The HTC teams partner with leading physicians from around the globe to develop innovative MedTech solutions that improve the quality of care for patients worldwide.

The company's work is built on a proud legacy of leadership in electrophysiology. What began in the 1990’s with the founding of Biosense has evolved to present-day expertise driving best-in-class solutions in cardiac ablation, stroke care, intracardiac imaging and navigated ENT surgery.

Innovation is at the forefront at the Haifa Technology Center. HTC has been the top patent applicant in Israel for a decade. To fuel its innovation, experts in systems engineering, software integration, image integration, ultrasound capabilities, 3D printing and miniature sensors work collaboratively to create solutions that improve physician workflow and patient outcomes. HTC is also embracing the future of patient care by pioneering next-generation digital solutions, such as cloud-based applications that are powered by artificial intelligence.

A culture of continuous learning gives HTC employees fresh perspective to fuel continuous innovation and growth. The company embraces the unique perspectives, backgrounds and ideas of its employees, and provides them a fascinating career path and an opportunity to impact patients' lives.

We are looking for a Quality Engineer Risk Management !

Main Responsibilities

• 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
  
  

• 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, coordinating, and evaluating 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