דרושים Design Transfer Intern ב-Ge Healthcare ב-Norway

Qualifications

• Bachelor’s degree or higher. Beneficial with technical degree.
• Working proficiency in writing and speaking English, proficiency in Norwegian is considered an advantage.
• Experienced in the area of engineering release and change process.
• Previous experience related to project management and planning would be considered an advantage.

Essential Responsibilities

• In close collaboration with program teams create product structures and item attributes for compliance with GE HealthCare procedures and national regulations for new and existing products.
• Drive design releases to manufacturing and own design change implementations according to company procedures and plans.
• Drive software update design change, including facilitation of electronic delivery of software updates.
• Creation and release of commercial product items and facilitate for product releases in content management system.
• Ensure changes are according to company quality and regulatory policies.
• Manage change notifications and distribute change documentation to suppliers.
• Participate in quarterly planning sessions with R&D to define and prioritize on deliverables together with the Design Change Control team.

Personal qualities

• You are a positive person with good team and cooperative skills.
• You are systematic and analytical by nature with attention to details.
• Ability to take ownership, be proactive and pivot between priorities in a dynamic environment.
• You are not afraid of questioning and taking responsibility in you daily work.
• You are skilled in working with software-based tools, specifically content-management

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

• 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.

Essential Responsibilities:

• Serve as the Quality Assurance lead within New Product Development (NPI) and Design Change projects.
• Ensure compliance with the GE Healthcare Quality Management System under ISO 13485 and other applicable standards and regulations. Review and approve QMS documentation and deliverables throughout all phases of NPI projects.
• Collaborate efficiently with Program Management teams from program initiation to completion. Manage the planning of Quality Assurance deliverables within the programs and ensure progress to plan.
• Partner with GE Healthcare Subject Matter Experts to identify solutions that are both lean and compliant with standards and regulations.
• Resolve compliance conflicts within projects.

Qualifications / Requirements:

• Bachelor's degree in Engineering or a relevant discipline.
• Proven experience in the field of Quality Assurance.
• Strong problem-solving skills, with the ability to manage and resolve conflicts and propose solutions to both internal team members and external clients.
• Operational mindset with the ability to translate strategy into action, demonstrating a strong sense of urgency to drive outcomes with speed and efficiency.
• Proficient in computer-based platforms and tools.
• Strong oral and written English communication skills.

Desired Characteristics:

• Prior experience in the healthcare industry.
• Experience with ISO 13485 Medical Device Quality Management standards and medical device regulations, such as 21 CFR 820.
• Demonstrated team orientation and ability to motivate and work well with diverse, cross-functional teams in matrixed settings.
• 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.