GE HealthCare · 4 hours ago
Senior Director, Site Quality, Waukesha South Operations
Waukesha, WI
Full-time
Onsite
Director/Executive
10+ years expGE HealthCare is a leading global medical technology and digital solutions innovator. The Senior Director, Site Quality, will oversee Quality Assurance activities at the Waukesha South Operations facility, ensuring compliance with internal and external requirements while driving quality metrics and leading cross-functional teams.
AppsHealth CareHealth DiagnosticsHome ImprovementHome RenovationInternetMedical
No H1B
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
Qualification
Required
Bachelor's Degree or a minimum of 14 years work experience
Minimum of 10 years working in a regulated medical device or pharmaceutical industry
Preferred
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
Benefits
Great work environment
Professional development
Challenging careers
Competitive compensation
Company
GE HealthCare
GE Healthcare provides a wide range of medical technologies and services to healthcare providers and researchers. It is a sub-organization of General Electric.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$5.52BKey Investors
Bill & Melinda Gates Foundation
2024-11-07Post Ipo Secondary· $1.17B
2024-09-12Post Ipo Secondary· $1.29B
2024-02-16Post Ipo Secondary· $1.07B
Leadership Team
Catherine Estrampes
President and CEO, US & Canada
Luiz Verzegnassi
President & CEO, Services
Recent News
Medical Device Network
2026-02-03
legacy.thefly.com
2026-02-02
Company data provided by crunchbase