GE HealthCare Director - QA 

Remote, Remote 

429276063

As Director - QA / Senior Director - QA, you will be part of the Central Q&R Organization. You will be responsible for the implementation and sustenance of Quality Management System and driving improvements within the Commercial organization including Channel Partners / Service Providers.Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards (Preventive). Interprets simple internal and external business challenges and recommends best practices to improve products, processes or services. Stays informed of industry trends that may influence work.

Roles and Responsibilities

• Creates a Quality culture by driving compliance activities in the region. This includes being responsible for the total 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.
• Requires specialized depth and/or breadth of expertise within their discipline. May require strong commercial awareness, and is expected to influence the development of strategy working with Channel Partners and Service Providers.
• Develop and implement processes and procedures for qualification, onboarding and monitoring / audit of Channel Partners and Service Providers. Implement QMS with external partners that is compliant with regulatory requirements.
• Problem solving, identifying root cause, implementing corrective actions and ensuring sustenance.
• 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 Recalls, CAPA, Quality Metrics, etc. Communicates complex messages and negotiates mainly internally with others to adopt a different point of view. Influences peers to take action and negotiate with external partners.
• Impacts the team's ability to achieve service, quality and timeliness of objectives. Work is subject to functional policy objectives. Regularly advises management in the function and/or in the business. Has a supportive role in decision making about important subjects. High levels of evaluative judgment are required to achieve outcomes required.
• Uses high level of judgment to make decisions and handle complex tasks or problems that impact the function. 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 from an accredited university or college
• Minimum 12 years’ experience in Quality Assurance / Regulatory Affairs

Desired Characteristics

• Strong oral and written communication skills.
• Experience leading and implementing change.
• Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.
• Strong interpersonal and leadership skills.
• Demonstrated ability to analyze and resolve problems.
• Demonstrated ability to lead programs / projects.
• Ability to document, plan and execute programs.
• Established project management skills.
• Prior experience as a Site QA Leader
• Strong auditing skills, certified ISO 13485 Lead Auditor

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.

Application Deadline: December 19, 2024