Ph3Job Description Summary /h3pThe QA Manager is accountable for leading Quality and Regulatory Compliance across multiple markets in Europe and supporting external distributors within the region. This role requires strong people leadership capabilities, deep knowledge of ISO9001 Quality Management Systems, and the ability to operate effectively in a highly matrixed, global environment. The QA Manager ensures that regional Quality processes are fully aligned with the GE HealthCare Global Quality Management System while driving continuous improvement, operational discipline, and a strong quality culture across internal teams and external partners. In this role, you will be responsible for the direct markets of Italy, France, and Spain, as well as supporting additional indirect markets across the EU region. /ph3Key Responsibilities /h3h3Leadership People Management /h3ulliLead, coach, and develop Quality team members across multiple EU markets to ensure operational excellence, compliance, and customer focus. /liliDrive engagement, clarity, and accountability within a multicultural and geographically dispersed team. /liliFoster a strong quality mindset, both internally and among distribution partners. /li /ulh3Quality Compliance Oversight /h3ulliDirect the regional Quality Management System, ensuring full integration with the GE Global QMS and compliance with ISO9001 and applicable country‑specific regulatory requirements. /liliServe as the primary Quality representative for regional compliance, including voluntary, regulatory, and company quality requirements. /liliEnsure readiness for audits and inspections at all sites within the region, including distributor GDP compliance. /li /ulh3Distributor Market Support /h3ulliOversee Quality compliance for internal and external distributors, ensuring proper implementation of GEHC quality requirements, documentation, and complaint management processes. /liliStrengthen quality governance with distributor partners, ensuring execution of corrective and preventive actions and alignment with ISO/GDP expectations. /liliBuild strong relationships with external partners and act as the key Quality point‑of‑contact for assigned markets. /li /ulh3Quality System Performance Continuous Improvement /h3ulliDrive development and monitoring of regional quality objectives, KPIs, and reporting mechanisms. /liliEnsure timely investigation and closure of Deviations, CAPAs, Complaints, and other quality events. /liliLead and participate in global quality initiatives to share best practices and leverage synergies across the PDx network. /li /ulh3Regulatory Audit Responsibilities /h3ulliAct as the Management Representative for Quality in the region. /liliParticipate in external audits and represent GE HealthCare to regulatory bodies and notified authorities. /liliEnsure compliance with Quality System Regulations, cGMP, QSR, ISO, and other international quality requirements. /li /ulh3Quality‑Specific Goals /h3ulliComplete all Quality Compliance training within deadlines. /liliIdentify and escalated quality issues and take immediate corrective action. /liliEnsure successful operation of internal inspection programs and closure of nonconformities. /liliCommunicate quality‑related updates and risks to site and regional leadership in a timely manner. /liliAchieve regional quality performance metrics as defined in annual objectives. /li /ulh3Qualifications /h3ulliBachelor's degree in Engineering, Life Sciences, Medical Device Technology, or related scientific field (or equivalent experience). /liliExperience in Quality within the medical device or pharmaceutical industry. /liliPeople‑leadership or managerial experience supporting cross‑functional teams. /liliHands‑on experience with ISO9001, FDA QSR, MDD/MDR, GDP, and other international quality standards. /liliDemonstrated experience conducting internal and external audits. /liliStrong analytical, problem‑solving, and decision‑making skills. /liliExcellent communication skills in Italian and English. /liliProficiency in data analysis, QMS tools, and digital platforms. /liliExperience working in a global, matrixed organization with multiple countries or regions. /liliProfessional certification as a Lead Auditor (nice to have). /liliSix Sigma training or certification (nice to have). /liliExperience building or transforming Quality Systems (nice to have). /liliOperational experience in Engineering, Manufacturing, or Supply Chain (nice to have). /li /ulh3Inclusion and Diversity /h3pGE HealthCare is an Equal Opportunity Employer where inclusion matters. 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. /ppRelocation assistance provided: No /p /p #J-18808-Ljbffr