Director, Quality QMS Compliance

Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.

How you will make an impact:

• Lead and oversee Quality Management System (QMS) activities at the Edwards Israel Innovation Center, including management review, audits, and CAPA.
• Manage Quality objectives while ensuring Quality System compliance with Edwards’ QMS, ISO 13485 and FDA 21 CFR part 820 (QMSR).
• Partner and collaborate with Operations, R&D and Project Management leaders to align and prioritize activities and to address quality issues.
• Manage and mentor the Quality team, including the sub-functions of Quality Control, Document Control, and Equipment/Software V&V; foster a strong quality culture and team engagement.
  
  

• Bachelor’s degree in Science / Technology / Engineering / Equivalent
• 6+ years of relevant experience in medical device industry.
• Deep, expert-level understanding of Quality processes within the medical device industry.
• Experience in QMS strategy and implementation for early-stage projects (design phases pre-launch) as well as process validation and design transfer to production.
• Demonstrated ability to manage teams, provide coaching and feedback and partnering with HR on employee relations.
  
  

• Experience in corporate/international companies.
• Management of team and sub-teams of 15+ employees.
• Background in multidisciplinary medical products (mechanical/hardware/software).
• Excellent documentation and communication skills (written and verbal), in both English and Hebrew.
• Strong interpersonal skills and the ability to build effective working relationships.
• Proven problem-solving, organizational, technical, and critical thinking abilities.
• High attention to detail, strong execution capabilities, and effective prioritization skills.