Director, Site Quality, Haifa at GE Healthcare

Haifa, Haifa District, Israel

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, ImagingIndustries

Requirements

Significant experience in Quality & Healthcare Quality
Knowledge level comparable to a Master's degree from an accredited university or college (or a high school diploma with relevant experience)
Strong leadership and communication skills
Previous project management experience preferred
Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485
Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production & process controls; Corrective & Preventive Action (CAPA), complaints & risk management
Demonstrated collaboration, negotiation & conflict resolution skills
Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance
Demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, manufacturing / production process control methodologies, and servicing in a medical device environment
Experience in a global working environment

Responsibilities

Leads a team of quality professionals who support the overall site Quality Management System, Design Quality and Production and Process Control Quality
Creates a Quality culture by driving compliance activities around a specific product, site or region, including responsibility for the total quality management system for the business and driving Quality metrics
Ensures quality and regulatory compliance while driving process effectiveness and efficiency
Displays deep expertise within quality, providing professional or thought leadership, defines and influences policy, and ensures delivery within quality, linking with other functions of the organization
Represents GE Healthcare to external agencies and champions the evolution of the quality culture, including executing and driving quality objectives, metrics, reporting and operating mechanisms
Leads cross-functional teams and projects with moderate to high resource requirements, risk, and/or complexity, and presents solutions to leaders in quality and other functions at the site
Influences quality decisions and operating guidelines impacting the site
Uses high level of judgment to make decisions and handle complex tasks or problems that impact quality, assesses quality of information given, and asks pertinent questions to stakeholders
Offers new solutions to problems outside of set parameters, constructs and provides recommendations using multiple internal and some external sources
Acts as a skilled influencer, communicates complex messages, serves as a resource for colleagues with less experience, leads small projects with moderate risks and resource requirements, explains difficult or sensitive information, and builds consensus

Skills

Quality Management System

Quality Assurance

Regulatory Compliance

Process Control

Design Quality

Total Quality Management

Quality Metrics

Cross-functional Leadership

Thought Leadership

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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