Quality Lead Specialist 1 - Healthcare Quality at GE Healthcare

Budapest, Hungary

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Bachelor’s degree in an engineering or technical discipline; or non-technical degree with a minimum 5 years of experience in manufacturing, engineering, or quality assurance
Minimum 3 years of experience working in a regulated industry
Strong knowledge base regarding Quality Management Systems (QMS)
Excellent communication skills both written and verbal
Ability to work independently as well as collaboratively across multiple disciplines
Proficiency in Microsoft Office Suite applications (Word, Excel, PowerPoint etc.)
Experience working with SAP system beneficial but not essential
Knowledge of ISO 13485, ISO 14971, 21CFR820, and other relevant international standards advantageous
Fluent English language skills essential – further languages beneficial but not essential
Willingness to travel occasionally if needed (<10%)

Responsibilities

Ensure compliance with quality standards throughout the product lifecycle by implementing effective procedures and controls related to design, development, testing, and servicing of medical devices
Collaborate with cross-functional teams to identify potential risks or issues associated with product design/development, production processes, or post market surveillance activities
Conduct audits regularly to assess adherence to established protocols for quality management systems (QMS)
Develop new methods or modify existing ones when necessary based on changing requirements or technological advancements
Work closely with internal stakeholders such as engineering, production, purchasing, regulatory affairs and sales teams to address any issues identified during audits or inspections promptly
Provide feedback on findings obtained from audits / inspections so appropriate actions can be taken to prevent recurrence of similar problems in future
Maintain product and site certifications through successful external audits
Lead audit readiness activities and represent GE HealthCare during external audits

Skills

Quality Assurance

Quality Management Systems

Medical Devices

Compliance

Audits

Risk Management

Product Lifecycle

Regulatory Affairs

Cross-functional Collaboration

QMS

GE Healthcare

Healthcare technology and data analytics provider

About GE Healthcare

GE Healthcare provides a range of healthcare technologies and services aimed at improving patient care. Its main products include imaging systems, mobile diagnostic devices, patient monitoring solutions, and advanced software for data analysis. These products help medical professionals make informed decisions and enhance the efficiency of healthcare delivery. Unlike many competitors, GE Healthcare invests significantly in research and development, allocating $1 billion each year to innovate and enhance its offerings. The company’s goal is to support healthcare providers in delivering better patient outcomes, as evidenced by its technology supporting over 300,000 patients daily and managing 2 billion patient scans each year.

Chicago, IllinoisHeadquarters

1892Year Founded

N/ACompany Stage

Data & Analytics, HealthcareIndustries

10,001+Employees

Risks

Emerging AR technologies increase competition in medical imaging.

Regulatory challenges may delay AI application expansions in healthcare.

Dependence on clinical trial success for new product market positioning.

Differentiation

GE Healthcare invests $1 billion annually in R&D for product innovation.

The company supports over 300,000 patients daily with its healthcare technologies.

GE Healthcare's AIR Recon DL offers 3D motion-insensitive imaging for enhanced MRI quality.

Upsides

Acquisition of Caption Health expands AI-powered ultrasound capabilities.

Successful Phase III trial of [18F]flurpiridaz enhances coronary artery disease detection.

Collaboration with Wayra accelerates digital health innovation in EMEA.

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