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Ensures that projects, processes and products are capable and will meet specified standards. The role will need to interpret simple internal and external business challenges and recommend best practices to improve products, processes or services withing Digital quality. Stays informed of industry trends that may influence work.Job Description
Roles and Responsibilities
- Creates a Quality culture by driving compliance activities around a specific product, site or region. This includes being responsible for the quality management system for the business and driving Quality metrics. Ensures quality and regulatory compliance while driving process effectiveness and efficiency. Represents GE HealthCare to external agencies and champions the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting and operating mechanisms.
- People leader with senior level direct reports. Deep expertise within quality to drive compliance and continuous improvement in Quality processes. Provides professional thought leadership. Influences policy and ensures delivery within Quality, linking with other functions of the organization.
- Will lead functional teams or projects with moderate to high resource requirements, risk, and/or complexity to drive continuous improvement within the quality system. Presents business solutions to leaders in the area of quality including but not limited to New Product Introductions, Recalls, CAPA, Quality Metrics.
- Communicates complex messages and negotiates mainly internally with others to adopt a different point of view. Influences peers to take action and may negotiate with external partners, vendors, or customers.
- The role influences policy/operating guidelines impacting Quality.
- Uses high level of judgment to make decisions and handle complex tasks or problems that impact Quality. Has ability to assess quality of information given and ask pertinent questions to stakeholders. Able to offer new solutions to problems outside of set parameters and is able to construct and provide recommendations. Uses multiple internal and some external sources outside of own function to help arrive at a decision.
Required Qualifications
Minimum of Bachelor's Degree in Engineering, Computer Science, Life Sciences or equivalent.
Minimum 10 years’ experience in Quality Assurance / Regulatory Affairs.
Minimum of 2 years’ experience as a people leader.
Desired Characteristics
Experience working with Software Medical Devices.
Experience working and communicating directly with external medical device regulators.
Experience in developing, implementing and maintaining quality system processes and driving improvements to processes.
Experience in cloud development and deployment of software medical devices.
Strong oral and written communication skills. Strong interpersonal and leadership skills. Demonstrated ability to analyze and resolve problems. Demonstrated ability to lead programs / projects. Ability to document, plan, market, and execute programs. Established project management skills.
GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
Relocation Assistance Provided: No
GE Healthcare Chicago, Illinois, USA Office
Chicago, IL, United States
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