GE HealthCare Quality Assurance Engineer - Manufacturing Transfer 

Norway 

673068104

• 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.

• 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.

• Prior experience in Healthcare industry

• Experience within ISO 13485 Medical Device Quality Management standard and Medical Device regulation, e.g. 21 CFR 820

• Prior experience in roles with demonstrated team orientation & ability to motivate and work well with diverse, cross- functional teams in matrixed settings

• Experience from change management projects

• Strong presentation skills

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration, and support.