Manager, Quality, PPC - Surgery

Job Description Summary This position is responsible for ensuring quality and regulatory compliance of a large facility, while driving process efficiency. The position provides key leadership to support the Supply Chain Activities at the Site, including Production and Process Control, Lean, and Supplier Quality. This position represents GEHC to external agencies and champions the evolution of the quality culture for the site which includes driving site quality objectives, metrics, reporting and operating mechanisms. Roles and Responsibilities Ensure quality and regulatory compliance while driving process effectiveness and efficiency. Represent GE HealthCare to external agencies and champion the evolution of the quality culture, executing quality objectives, metrics, reporting and operating mechanisms. Maintain and improve all aspects of Site Quality Planning. Serve as a people leader with direct reports. Exercise authority to stop production, issue product holds, make decisions about budgets and people accountability, release products and sign off on project milestones such as New Product Introduction. Oversee all Quality-related communications and training requirements for all site employees. Maintain positive agency relationships and liaise with regulatory agencies during site inspections. Participate in external technical forums. Ensure site audit readiness, host Quality System audits and inspections. Support Corrective Action / Preventive Action activities and report on Quality System effectiveness and requirements to management. Drive the definition of site quality objectives, metrics, reporting and operating mechanisms. Required Qualifications Bachelor’s degree and minimum of 6 years working in a regulated medical device or pharmaceutical industry (or high school diploma with 10+ years working in a regulated medical device or pharmaceutical industry). Minimum of 2 years supervisory/management or project leadership experience. Ability to communicate effectively in English (both written and oral). Demonstrated experience using word processing, spreadsheet, and presentation software. Understanding of Medical Device QMS requirements and regulatory requirements including FDA CFR 21 820 and ISO 13485. Hands‑on experience with FDA, QSR, ISO, MDD and/or other international quality systems requirements. Desired Characteristics Preferred minimum of 5 years supervisory/management experience. Proven process development and project management skills. Ability to lead, acknowledge, develop, communicate and implement a strategy under crisis situations to ensure compliance. Experience working in a cross‑functional environment and proven ability to influence and build consensus among multiple functions. Excellent written and oral communication skills. Knowledge of Quality Management System tools, continuous improvement methodologies and in-depth understanding of site‑level products and related processes. Ability 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; and product quality improvement using tools such as Six Sigma, DFR, etc. Experience leading, implementing, and accelerating change. Strong influencing, relationship building, mentoring and networking skills. Collaboration and conflict resolution skills. Track record in performing and leading internal and external audits. Exceptional analytical, problem solving and root‑cause analysis. Relocation assistance provided: Yes. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). 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. #J-18808-Ljbffr F39055 OEC Medical Systems, Inc.