ISC Quality Leader

Job Title
ISC Quality Leader

Job Description

As a Quality Leader for the factory in Haifa, you will lead the efforts to establish and maintain the Quality Management System that manufactures systems for the business unit of CT/ AMI.

As part of the Quality team, you will ensure that every (sub) system and component manufactured is compliant with all applicable regulations. Moreover, you will drive continuous improvement, in process and on parts and system level.

Your role:

• Ensuring all systems and components are manufactured in a compliant way and meet all the required specifications.
• Maintaining the Quality Management System.
• Acting as the Site Management Representative in external and internal QMS audits and inspections.
• Managing the Quality team in the Haifa factory.
• Being part of the local management team in Haifa, representing manufacturing quality.
• Participating in and driving daily management to ensure that targets are met in the areas of compliance and Quality.
• Realizing quality and compliance targets
• Overseeing/ managing Process validation and process FMEA.
• Being accountable for CAPA and NC process, including managing non-conforming material and CAPA records.
  
  

• A Masters or Bachelor's degree in Engineering, Science or other technical fields
• A minimum of 10 years of experience in the Medical Device field and specifically familiar with Class II and experience in quality management
• A minimum of 5 years of experience in a leadership role
• Technical knowledge and experience in manufacturing
• Demonstrated knowledge of 21 CFR part 820 and ISO 13485
• Experienced in establishing strategy and keeping oversight
• Strong communication, interpersonal and stakeholder management skills
• Excellent organizational skills
• Assertive mindset: can-do mentality
• Ability to demonstrate high-performance behavior of shared accountability, self-growth and growing others in order to improve processes and systems.
  
  

• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.