Quality Lead Specialist - Healthcare Quality at GE Healthcare

Waukesha, Wisconsin, United States

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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 TechnologyIndustries

Requirements

Bachelor's degree from an accredited university/college or a minimum of 6 years of relevant work experience in Medical Devices, or similar regulated industry
Minimum of 3 years of experience working in a regulated industry
Ability to communicate effectively in English (both written and oral)
Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications

Responsibilities

Creates a Quality culture by driving compliance activities around a specific product, site or region
Responsible for the total quality management system for the business and driving Quality metrics
Ensures quality and regulatory compliance while driving process effectiveness and efficiency
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
Provides manufacturing and/or engineering process support in accordance with documented procedures and practices
Develops, implements, improves and continuously reinforces established Quality Management System practices, product specifications and applicable standards
Collaborates within the areas of design, design transfer, manufacturing, distribution, and service
Develops in-depth knowledge of the product and processes, using prior experience and acquired expertise to execute functional policy/strategy
Communicates with direct colleagues and the business about design and related processes (design transfer, manufacturing, distribution, and service)
Provides guidance to team members and explains complex information to others in straightforward situations
Impacts projects, processes and procedures in own field, operating with some autonomy within a team environment focused on execution of activities/processes
Utilizes technical expertise and judgement to solve problems, leveraging technical skills and analytic thinking, and may use multiple internal sources outside of own team to arrive at decisions

Skills

Quality Management System

QA Engineering

Regulatory Compliance

Process Improvement

Manufacturing Processes

Design Transfer

Quality Metrics

Total Quality Management

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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