Senior Engineer, Design Quality Assurance

Your Responsibilities

• Drive the design & execution of Production Release Process project for components & finished devices
• Lead and implement complex projects including quality improvement initiatives
• Sets direction for cross-functional teams and drives towards compliant and efficient solutions to complex problems
• Lead Process/Design Risk Analysis
• Lead product Design Control activities for new product development efforts
• Provide leadership in understanding of the quality regulations to other disciplines
• Support Process/Design Validation/Verification activities and approach including software validation
• Lead implementing limited cost of quality concepts, including cost of quality, data collection, & reporting
• Support Manufacturing Engineering in the creation of DMR, DHR, routes, and bills of material, print changes, and specifications for in-house / external manufacturing
• Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times
  
  

• Bachelors Degree in an Engineering discipline is required
• Minimum of 5 years experience in Quality Engineering in FDA regulated environment
• Knowledge of Six Sigma tools and problem solving
• Experience with sustaining engineering and post-market surveillance
• Knowledge of FDA QSR, ISO 13485, ISO 14971, ISO 11135, EU MDR
• Strong communication skills
• Ability to work in fast paced environment
  
  

• Patient Focus - We put patients at the heart of everything
• Integrity - We do the right thing
• Innovation - We look for new ways to make things better
• Impact - We take accountability and get things done
• Empathy - We care for one another and work together
  
  

• We offer a competitive salary and a locally competitive benefits package designed for employees based in Israel. In addition to statutory employment benefits, you'll have access to company benefits that support your wellbeing, development, and work-life balance. We'll be happy to share the full details during the interview process.