F) at GE Healthcare

Bucharest, Bucharest, Romania

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Bachelor’s degree in engineering, Life Sciences, Quality, or a related technical field
Experience in Quality Assurance within the medical device, healthcare, or regulated industry
Strong knowledge of ISO 13485, EU MDR, and other applicable international regulations
Experience in internal and external audits

Responsibilities

Act as the focal point for QA in the Vega Zone, French speaking LCTs, supporting Sales, Service, and operational teams
Participate in the maintenance and update of the QMS, including Site Quality Plans (SQPs), local procedures, and training compliance
Ensure understanding and adherence to quality procedures across the Region
Lead and support internal and external audits, including regulatory inspections
Monitor and report on QMS training status; co-accountable for training completion in the zone
Coach and mentor teams on the development, maintenance, and simplification of local procedures
Provide guidance to business managers on quality topics and regulatory expectations
Drive the CAPA process by identifying quality concerns, conducting spot audits, and ensuring timely corrective actions
Lead or support quality improvement projects and QPTPs (e.g., repair center setup, office moves, harvesting)
Manage deviation/concession processes and ensure compliance with tool calibration and OOT requirements
Support channel partner quality oversight, including Annex Q adherence and audit readiness
Collaborate with the Supplier Quality team to ensure use of qualified suppliers
Support closure of customer complaints, field actions, and non-conformances
Participate in remote internal audits as lead auditor or SME
Collaborate with the regional RA team to ensure alignment on regulatory requirements, audit readiness, and product compliance
Represent the Vega zone in INTERNATIONAL region and global QA forums and initiatives

Skills

Key technologies and capabilities for this role

Quality AssuranceQuality Management SystemQMSRegulatory ComplianceAuditsInspectionsRegulatory Affairs

Questions & Answers

Common questions about this position

What is the employment type for this QA Leader position?

This is a full-time position.

Is this QA Leader role remote or does it require specific location?

This information is not specified in the job description.

What are the main responsibilities for the QA Leader role?

Responsibilities include leading QA activities across French-speaking countries in Zone Vega, implementing and maintaining the QMS, supporting audits and inspections, acting as QA interface for Sales and Service teams, and collaborating with RA and global quality functions.

What is the team structure or collaboration like in this role?

You will collaborate closely with the regional Regulatory Affairs (RA) team, QA peers in the VEGA Zone and INTERNATIONAL region, as well as global quality functions, while leading and coordinating QA activities across French-speaking countries.

What makes a strong candidate for the QA Leader position?

Strong candidates should have leadership experience in QA, expertise in Quality Management Systems, audit support, regulatory compliance, and the ability to coach teams and drive CAPA processes across diverse geographies.

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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