Quality Leader
GE HealthCare
This listing was originally posted on GE HealthCare's careers page. Formulate is an equal opportunity job aggregator and is not involved in the hiring process. Where salary information is estimated, it is derived from BLS industry benchmarks and may differ from actual compensation.
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Upgrade to Pro — $25/moResponsibilities
Quality Leadership & Culture
Promote and reinforce a strong Quality culture within assigned teams and processes.
Lead compliance activities for designated products, processes, or site operations focusing on Hungary.
Lead the deployment and maintenance of the Total Quality Management System (TQMS) at site level.
Drive and contribute to quality objectives, metrics, and reporting.
Act as a site‑level quality partner to operations, engineering, and service teams and representi GE HealthCare in interactions with external agencies .
Quality Systems & Compliance
Ensure day to day compliance with applicable quality and regulatory requirements. while improving process efficiency.
Maintain and improve quality procedures, work instructions, and documentation.
Monitor quality performance indicators and support continuous improvement initiatives.
Participate in internal and external audits as a site representative, with guidance from senior Quality leaders.
Support the evolution of quality processes and standards across the organization.
Bachelor’s degree.
Experience in Quality Assurance, Quality Engineering, design engineering, or manufacturing engineering within the medical device or pharmaceutical sector.
Working knowledge of Quality Management System tools, continuous improvement methodologies, and site‑level product and process requirements.
Strong ability to communicate effectively in English and Hungarian (written and verbal).
Proficiency in MS Office applications (Word, Excel, PowerPoint, databases).
Experience in coordinating workstreams or projects.
Demonstrated understanding—or strong aptitude to learn—Medical Device QMS and regulatory requirements, including FDA 21 CFR 820 and ISO 13485.
Master’s degree or PhD in Engineering or a technical discipline.
Ability to communicate effectively across all organizational levels on topics such as:
design controls,
design verification and validation,
production and process controls,
CAPA,
complaints handling,
risk management,
product quality improvement (e.g., Six Sigma, DFR).
Demonstrated collaboration and conflict‑resolution skills.
Experience with systems such as MyWorkShop, TrackWise, Pega, Excel Software, and strong project management capabilities.
Understanding of:
product development lifecycle,
design and document change control,
process verification and validation,
manufacturing and production process controls,
service operations in a medical device environment.
Knowledge of continuous improvement tools (e.g., DMAIC, SPC, Lean Six Sigma, 5S).
Experience in leading and implementing change.
Experience conducting internal and external audits.
Exceptional analytical, problem‑solving, and root‑cause analysis skills.
Strong technical aptitude, including the ability to read and interpret technical documentation and execute procedures.
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership –always with unyielding integrity.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
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Relocation Assistance Provided: No
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