Quality Assurance Lead Engineer at GE Healthcare

Waukesha, Wisconsin, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Healthcare, Medical Technology, Diagnostic CardiologyIndustries

Requirements

Bachelor’s degree in an engineering or technical discipline; OR High School Diploma with a minimum 7 years of experience in manufacturing, engineering, or quality assurance
Minimum 3 years of experience working in a regulated industry
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
Legal authorization to work in the U.S. (no sponsorship for employment visas)

Responsibilities

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
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 engineering processes and QMS management support in accordance with documented procedures and practices
Develops, implements, improves and continuously reinforces established Quality Assurance fundamental practices utilized in the local business, including areas of design, design transfer, and deployment of the QMS for the Diagnostic Cardiology business segment
Uses prior experience and acquired expertise to execute functional policy/strategy
Communicates with direct colleagues and the business about design and coordination services rendered
Provides informal guidance to new team members
Explains complex information to others in straightforward situations
Impacts projects, processes, and procedures in own field
Utilizes technical expertise and judgement to solve problems
Leverages technical skills and analytic thinking required to solve problems
May use multiple internal sources outside of own team to arrive at decisions

Skills

Key technologies and capabilities for this role

Quality AssuranceQMSQuality Management SystemRegulatory ComplianceProcess ImprovementDesign TransferMetrics ReportingTotal Quality Management

Questions & Answers

Common questions about this position

What are the required qualifications for the Quality Assurance Lead Engineer role?

Candidates need a Bachelor’s degree in an engineering or technical discipline or a High School Diploma with at least 7 years of experience in manufacturing, engineering, or quality assurance, plus a minimum of 3 years in a regulated industry and understanding of Medical Device QMS requirements like FDA CFR 21 820 and ISO 13485.

Is visa sponsorship available for this position?

No, GE Healthcare will not sponsor individuals for employment visas now or in the future for this job opening.

What is the employment type for this role?

This is a full-time position.

What does the company culture emphasize at GE Healthcare?

GE Healthcare fosters a culture where every voice makes a difference, driving a Quality culture through compliance activities, metrics, and objectives to build a healthier world.

What salary or compensation is offered for this position?

This information is not specified in the job description.

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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