JOB DESCRIPTION SUMMARY

The Manufacturing Transfer QA Engineer will be the lead Quality Assurance resource in our Manufacturing Transfer projects under the ISO 13485 Medical Device Quality Management standard. The role is responsible for identifying and executing the changes needed to Quality Management System and registrations and will support the program team to execute the Transfer of Production. The role will work interactively with the Program Manager and the other functional roles within the project organization.
This position reports to the Quality Assurance Director of the GE Healthcare Cardiovascular Ultrasound facility in Horten Norway.

REQUIRED QUALIFICATIONS

• Bachelor’s degree in engineering or other relevant discipline
• Experience (3+ yrs) in the field of Quality Assurance
• Demonstrated ability to plan, lead and execute projects
• Solid problem-solving skills (ability to manage and resolve conflicts and propose solutions to both internal team members and external clients)
• Operational mindset and ability to translate strategy into action, with strong sense of urgency to drive outcomes with speed and efficiency
• Understanding of change management processes
• Proficient skills within computer-based platforms and tools, e.g. Salesforce, MS Office
• Strong oral and written English communications skills
• Willingness to travel internationally, when needed in transfer projects.

• Be the Quality Assurance lead resource within Manufacturing Transfer projects, both for internal transfer projects (between GEHC sites), as well as transfers to external (non-GEHC) Manufacturing sites.
• Ensure compliance to the GE Healthcare Quality Management system under ISO 13485, and other applicable standards and regulation. Be the reviewer and approver of QMS documentation and deliverables throughout all phases of the transfer project.
• Efficiently interact and cooperate with the Transfer Program Manager, Manufacturing, Engineering and Regulatory Affairs, from project initiation until completion. Manage planning of the Quality Assurance deliverables within the transfer projects, and ensure progress to plan.
• Partner with GE Healthcare Subject Matter Experts to identify solutions that are both lean and compliant to standards and regulation.
• Where applicable, provide Quality Assurance support for external transfers (non-GEHC), post implementation.
• Resolve compliance conflicts within the projects.