Quality Leader at GE HealthCare
**Who this is for** A seasoned quality professional with a background in the medical device or pharmaceutical sector, looking to lead and influence quality cult
Work type: onsite
Location: HUN04-01-Paty-Csonka Janos 1-3
Type: Full-time
Summary
**Who this is for** A seasoned quality professional with a background in the medical device or pharmaceutical sector, looking to lead and influence quality culture at the site level.
**Key highlights** This leadership position involves maintaining the Total Quality Management System (TQMS) and ensuring that products meet stringent regulatory standards, including FDA 21 CFR 820.
**You might be a good fit if you...**
- Hold a degree in a technical discipline with proven experience in quality assurance or engineering.
- Have expert knowledge of medical device regulatory requirements and continuous improvement methodologies like Six Sigma.
- Are skilled at representing the organization during external audits and managing complex cross-functional projects.
- Possess strong analytical abilities to identify root causes and drive CAPA initiatives.
Job Description
# Job Description Summary
GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.
As a Quality Leader, you will develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Your scope will also include ensuring that projects and products are capable and will meet specified standards (Preventive).
# Job Description
ResponsibilitiesQuality Leadership & Culture
- Building and promoting a strong Quality culture across the business.
- Leading compliance activities for designated products, sites, or regions.
- Owning and maintaining the Total Quality Management System (TQMS).
- Driving quality objectives, metrics, reporting, and operating mechanisms.
- Representing GE HealthCare in interactions with external agencies and regulatory bodies.
Quality Systems & Compliance- Ensuring adherence to quality and regulatory requirements while improving process efficiency.
- Maintaining and enhance quality systems, procedures, and documentation.
- Monitoring quality performance and driving continuous improvement initiatives.
- Supporting the evolution of quality processes and standards across the organization.
## Required Qualifications
- Experience in Quality Assurance, Quality Engineering, design engineering, or manufacturing engineering within the medical device or pharmaceutical sector.
- Strong knowledge of Quality Management System tools, continuous improvement methodologies, and site‑level product and process requirements.
- Strong ability to communicate effectively in English (written and verbal).
- Proficiency in MS Office applications (Word, Excel, PowerPoint, databases).
- Experience in managing project teams.
- Demonstrated understanding—or strong aptitude to learn—Medical Device QMS and regulatory requirements, including FDA 21 CFR 820 and ISO 13485.
## Desired Characteristics- Master’s degree or PhD in Engineering or a technical discipline.
- Ability to communicate effectively across all organizational levels on topics such as:
- design verification and validation,
- production and process controls,
- 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.
- 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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# Additional Information
Relocation Assistance Provided:No
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