Quality Assurance Manager, Regional Quality

Job Description Summary

The 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.

Key Responsibilities

Leadership & People Management

• Lead, coach, and develop Quality team members across multiple EU markets to ensure operational excellence, compliance, and customer focus.
• Drive engagement, clarity, and accountability within a multicultural and geographically dispersed team.
• Foster a strong quality mindset, both internally and among distribution partners.

Quality & Compliance Oversight

• Direct the regional Quality Management System, ensuring full integration with the GE Global QMS and compliance with ISO9001 and applicable country‑specific regulatory requirements.
• Serve as the primary Quality representative for regional compliance, including voluntary, regulatory, and company quality requirements.
• Ensure readiness for audits and inspections at all sites within the region, including distributor GDP compliance.

Distributor & Market Support

• Oversee Quality compliance for internal and external distributors, ensuring proper implementation of GEHC quality requirements, documentation, and complaint management processes.
• Strengthen quality governance with distributor partners, ensuring execution of corrective and preventive actions and alignment with ISO/GDP expectations.
• Build strong relationships with external partners and act as the key Quality point‑of‑contact for assigned markets.

Quality System Performance & Continuous Improvement

• Drive development and monitoring of regional quality objectives, KPIs, and reporting mechanisms.
• Ensure timely investigation and closure of Deviations, CAPAs, Complaints, and other quality events.
• Lead and participate in global quality initiatives to share best practices and leverage synergies across the PDx network.

Regulatory & Audit Responsibilities

• Act as the Management Representative for Quality in the region.
• Participate in external audits and represent GE HealthCare to regulatory bodies and notified authorities.
• Ensure compliance with Quality System Regulations, cGMP, QSR, ISO, and other international quality requirements.

Quality‑Specific Goals

• Complete all Quality & Compliance training within deadlines.
• Identify and escalated quality issues and take immediate corrective action.
• Ensure successful operation of internal inspection programs and closure of nonconformities.
• Communicate quality‑related updates and risks to site and regional leadership in a timely manner.
• Achieve regional quality performance metrics as defined in annual objectives.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Medical Device Technology, or related scientific field (or equivalent experience).
• Experience in Quality within the medical device or pharmaceutical industry.
• People‑leadership or managerial experience supporting cross‑functional teams.
• Hands‑on experience with ISO9001, FDA QSR, MDD/MDR, GDP, and other international quality standards.
• Demonstrated experience conducting internal and external audits.
• Strong analytical, problem‑solving, and decision‑making skills.
• Excellent communication skills in Italian and English.
• Proficiency in data analysis, QMS tools, and digital platforms.
• Experience working in a global, matrixed organization with multiple countries or regions.
• Professional certification as a Lead Auditor (nice to have).
• Six Sigma training or certification (nice to have).
• Experience building or transforming Quality Systems (nice to have).
• Operational experience in Engineering, Manufacturing, or Supply Chain (nice to have).

Inclusion and Diversity

GE 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.

Relocation assistance provided: No