Site Quality Leader

Business Unit: GE HealthcareFunction: QualityResponsibilities: The successful candidate in this leadership role will direct the Site Quality Management System, fully integrated into the GE Healthcare Clinical Systems Global Quality Management System, including cross-functional and site-specific processes. The person in this role is responsible for facility compliance covering voluntary, regulatory and company quality requirements and will champion quality initiatives at all levels of the organization.He/she will:Maintain and improve all aspects of Site Quality PlanningOversee communications and training requirements for Quality matters to all site personnelEstablish and maintain positive relationships with outside agenciesHost Quality System audits and inspectionsLead Corrective Action/Preventive Action activitiesPrepare and execute facility Quality Management ReviewsDrive the definition of site quality objectives, metrics, reporting and operating mechanismsParticipate in selected global initiatives for best practice sharing and quality synergiesBe the primary communicator for quality issues, initiatives, practices, coming into and flowing from LSSSupport local R&D programs and quality issue resolution~HJ~
REQUIREMENTS
Qualifications: * BS in Engineering or other technical area, or medical technology/caregiver degree/certification
3-5 years work experience with Quality or Regulatory issues, preferably in the medical device industry
Understanding of product development, manufacturing, quality control and servicing in a medical device environment
Hands-on experience with FDA QSRs, ISO, MDD, MHLW, SFDA, TGA, Canada MDR
Proven history of performing & leading internal and external audits
Ability to read, analyze and interpret business plans, technical procedures and domestic and international government regulations and voluntary standards
Effective report, business correspondence and procedure-writing skills
Effective process development and process management skills
Good problem identification, analysis and solving skills
Well-developed team player experience and skills, operating with a global mindset
Excellent communication, influencing and interfacing skills
Capable of multi-tasking and handling tasks with competing priorities effectively
Strong computer and e-skillsDesired: * MS/MA in technical or healthcare-related field
Anesthesia, respiratory care or critical care clinical application and medical device knowledge
Six Sigma Black Belt Certification
Project Management
Lead Auditor Certification
Building a ground-up quality system experience
Front line operational responsibility in Engineering, Manufacturing or SourcingGeneral: The Life Support Solutions Site Quality Manager ensures full quality and regulatory compliance of the Madison facility, while driving process effectiveness and efficiency. The successful candidate for this role will represent GE Healthcare to external agencies, and through effective interface with the global central quality team, will champion the evolution of the quality culture for the Madison site, while communicating best practices to the other GE Healthcare businesses.
GE is an equal opportunity employer, offering a great work environment, challenging career opportunities, professional training and competitive compensation.The United States has regulations that govern the hiring of current or former U.S. Government employees. If you currently work for (or have in the past) the U.S. Government (in any capacity), you may have certain responsibilities under these regulations and certain restrictions may apply to your potential employment with GE. Therefore, if you are contacted by GE regarding a position of employment, and you have worked for the U.S. Government at any time, please immediately inform the GE representative of this fact.