Sr Lead Specialist

Job Description Summary

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). In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area.

Job Description

Roles and Responsibilities

• Creates a Quality culture by driving compliance activities around Digital/Software products that may nor may not be for medical applications, and for certain sites or regions. 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.
• This is 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.
  
  

Required Qualifications

• This role requires advanced experience in the Quality & Healthcare Quality. Knowledge level is comparable to a Bachelor's degree from an accredited university or college ( or a high school diploma with relevant experience).
• Experience with driving quality assurance and compliance for Digital/Software products.
• Experience key QMS elements- including but not limited to CAPA, Risk Management and Design Controls.
  
  

Desired Characteristics

Experience in AI/ML/Data Science.

Experience in Cybersecurity and Privacy

Additional Information

Relocation Assistance Provided: No