Quality Assurance Lead Engineer

This position is responsible for providing engineering processes and QMS management support in accordance with documented procedures and practices. This is a key technical/management role responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the local business, including areas of design, design transfer, and deployment of the QMS for the Patient Care Solutions business.

This position is responsible for providing engineering processes and QMS management support in accordance with documented procedures and practices. This is a key technical/management role responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the local business, including areas of design, design transfer, and deployment of the QMS for the Patient Care Solutions business.

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• Creates a Quality culture by driving compliance activities around a specific product, site or 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.
• Developing in-depth knowledge of a discipline.
• Uses prior experience and acquired expertise to execute functional policy/strategy.
• A job at this level is likely to be an individual contributor, with proven interpersonal skills.
• Communication with direct colleagues and the business about design and coordination services rendered.
• Provides informal guidance to new team members.
• Explains complex information to others in straightforward situations.
• Impacts projects, processes, and procedures in own field.
• The role operates with some autonomy but is focused on execution of activities/provision of advice within an enabling discipline covered by standard functional practices and procedures.
• Activities require professional judgment but may require more senior levels of guidance.
• Utilizes technical expertise and judgement to solve problems.
• Leverages technical skills and analytic thinking required to solve problems.
• May use multiple internal sources outside of own team to arrive at decisions.

• Bachelor’s degree in an engineering or technical discipline; OR High School Diploma with a minimum 7 years of experience in manufacturing, engineering, or quality assurance.
• Minimum 3 years of experience working in a regulated industry.
• 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.
• Willingness to work a hybrid schedule with three days per week on-site at the GE Health Care office located in Waukesha, Wisconsin
• Demonstrated flexibility in approach to work hours, and willingness to partner with and accommodate global teams and schedules

• Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes.
• Demonstrated…