Senior Director, Site Quality, Waukesha South Operations

Job Description Summary

Job Description

Roles and Responsibilities

• Leads a team of quality professionals who support the overall site Quality Management System, Design Quality and Production and Process Control Quality.
• 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.
• Displays deep expertise within quality, providing professional or thought leadership. Defines and influences policy and ensures delivery within quality, linking with other functions of the organization.
• 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.
• Will lead cross-functional teams and projects with moderate to high resource requirements, risk, and/or complexity. Presents solutions to leaders in quality and other functions at the site.
• This role has a major influence on quality decisions and operating guidelines impacting the site.
• 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 can construct and provide recommendations. Uses multiple internal and some external sources outside of own function to help arrive at a decision.
• Skilled influencer, able to communicate complex messages to others. Acts as a resource for colleagues with less experience. May lead small projects with moderate risks and resource requirements. Explains difficult or sensitive information; works to build consensus. Developing persuasion skills required to influence others on topics within field.

Required Qualifications

• Bachelor's Degree or a minimum of 14 years work experience.
• Minimum of 10 years working in a regulated medical device or pharmaceutical industry.

Desired Characteristics

• Strong leadership and communication skills. Previous project management experience is preferred. 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. Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production & process controls; Corrective & Preventive Action (CAPA), complaints & risk management.
• Demonstrated collaboration, negotiation & conflict resolution skills. Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance. Demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, manufacturing / production process control methodologies, and servicing in a medical device environment. Experience in a global working environment.
• Experience leading and implementing change. Experience in performing internal audits and participating in external audits.
• Exceptional analytical, problem solving & root-cause analysis skills. Ability to multi-task & handle tasks with competing priorities effectively. Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & demonstrated experience interfacing with regulators.

​

Additional Information

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.