Lead Quality Engineer at GE Healthcare

Haifa, HA, 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, UltrasoundIndustries

Requirements

Bachelor's Degree in a scientific discipline and a minimum of 5 years working experience in the medical device industry and/or 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
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
Preferred: Demonstrated ability to develop & lead process implementation
Preferred: Experience with design controls, design verification and validation activities, SDLC, Design Transfer, Design changes; CAPA, complaints and risk management; Root Cause Analysis tools; Production and process controls
Preferred: Experience conducting internal audits
Preferred: Lean Certification
Preferred: Demonstrated effective interpersonal and networking skills
Preferred: Prior experience using word processing, spreadsheet, and presentation software
Preferred: Demonstrated ability to successfully comprehend & carry out/execute actions
Preferred: Effective oral and written communication skills
Preferred: Analytical & problem-solving skills/root-cause analysis
Preferred: Conflict-resolution skills
Preferred: Ability to prioritize and drive multiple programs
Preferred: Integrity: Accepting and adhering to high ethical, moral, and personal values in decisions, communications, actions, and when dealing with others
Preferred: Accepting constructive criticism and dealing calmly and effectively with high-stress situations, including continuing to persevere and remaining calm in challenging or frustrating circumstances
Preferred: Energizing others by building a connection with the team through personal involvement and trust and providing feedback and coaching to help develop others
Preferred: Simplifying strategy into specific actions with clear accountability, making decisions with speed and accuracy based on best available information, and communicating priorities clearly and concisely

Responsibilities

Manage quality systems, processes, and procedures to assure product safety, quality, and site compliance by driving business alignment to industry requirements for the Haifa PoC Ultrasound business
Responsible for compliance across Ultrasound business – Design Controls
Strategic partner with supporting functions – Sourcing, Supplier Quality, and Service
Provide leadership and facilitate problem resolution, and mentor team members, including accountable to ensure, follow up, and/or implement corrective actions that are raised by deviations, internal audit, or regulatory inspection
Create a Quality culture by driving compliance activities for the Haifa PoC Ultrasound business, including being responsible for the total quality management system for the business and driving Quality metrics, including engaging strong intradepartmental and cross-functional/organizational relationships to drive Quality System Requirements (QSRs)
Drive execution for all key quality system metrics; Own Quality Compliance Scorecard and facilitate appropriate operating mechanisms to ensure quality objectives are met
Lead efforts regarding continuous improvement projects across Ultrasound Business

Skills

Design Controls

Quality Management System

ISO 13485

FDA CFR 21 820

MS Office

Quality Metrics

Corrective Actions

Continuous Improvement

Regulatory Compliance

Medical Device 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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