Biosense Webster is recruiting for a NPD Quality Manager, located in Haifa, Israel.
NPD Quality Managers are responsible for leading the QA team supporting the design and development of new products in compliance with Biosense Websters Quality System. This role executes quality and business strategy for our new products, collaborating closely with global sites in identifying and implementing design and manufacturing solutions, ensuring effective and timely product launches.
Biosense Webster's new product development teams realize our future success in delivering innovative effective medical devices to achieve successful outcomes in the treatment of cardiac arrhythmia.
• Lead QA Project Team members on key product design development activities.
• Participate on multi disciplined design development teams as the Quality and Compliance representative, partnering, interacting and providing input to groups such as, R&D, Software Development, Regulatory, Manufacturing, Marketing, and Product Managers.
• Communicating and partnering with external development and manufacturing partners, relative to GMP issues, project plans, due dates, problem identification and resolution.
• Ensure compliance with Health Software and Design Control requirements for Medical Devices and Medical Device software. Lead and contribute to the generation of our products risk management file
• Serve as a representative on Design Review Committees, including as an independent reviewer.
• Monitoring of data applicable to product development and timely communication of quality, project and/or business related issues or opportunities to next management level.
Technical/Engineering/Scientific Degree, minimum.
Experience and Skills:
• Detailed knowledge of medical device design, manufacturing and applicable Quality Management Standards and regulations, including device software development.
• Comprehensive understanding of principles and concepts of Manufacturing Excellence, Statistical Process Control and Applied Statistics. Lean or Six Sigma Certification beneficial.
• Strong project management skills with an ability to lead and prioritize multiple initiatives in a dynamic environment to agreed timelines are required.
• Ability to accurately analyse and concisely communicate project and departmental information
• Prior experience in audit facing role as part of EU Medical Device Regulation, ISO13485 and/or the Medical Device Single Audit Program
Excellent verbal, written and presentation skills are required. Proficiency in written and spoken English is required.
Infrequent international travel may be required as a member of a global product development team.
Working hour flexibility to reasonably facilitate international team members desirable.
Quality Auditor Certification beneficial.