QA Program Manager at GE Healthcare

Bengaluru, Karnataka, India

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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/Masters degree in Engineering
7-10 years of relevant experience in Quality Assurance preferably in Medical Devices, Pharma or Life Sciences industry
Strong understanding of ISO 13485, FDA 21 CFR Part 820, & risk management (ISO 14971)
Hands on experience in Supplier qualification, Audits, Change control, Document control, and validation
Proficient in CAPA process and use of Problem-solving tools
Strong oral and written communication skills
Demonstrated ability to analyse and solve problems
Ability to document, plan, and execute programs
Experience in leading and implementing a change
Strong auditing skills. Preferred Lead auditor in ISO 13485, ISO 9001
Strong accountability and ability to influence without authority

Responsibilities

Ensure effective implementation and maintenance of QMS procedures, Work Instructions
Lead day to day operations ensuring adherence to Global Regulations and Standards
Review and approve quality documentation, change controls and deviations
Conduct internal and external audits
Lead investigations and risk assessment
Review and analyse product complaints, non-conformances to drive CAPA
Conduct training for quality awareness and process adherence across Channel partners and Service providers
Monitor key quality metrics and drive performance improvements
Work with cross functional team to foster culture of quality and continuous improvement
Drive quality and compliance with Channel Partners and Service providers, including quality plan implementation
Review and recommend procedural changes, develop simplified process including automation
Select Channel partners/Service providers through qualification processes
Own Channel partners/Service provider QMS, drive improvements utilizing scorecards
Own Channel partners/Service providers audits, ensuring compliance, and driving improvement plans where needed
Identify simple internal and external business challenges and implement best practices to improve products, processes or services

Skills

QMS

Quality Management System

Audits

CAPA

Risk Assessment

Change Controls

Deviations

Non-conformances

Scorecards

Quality Metrics

Process Improvement

Automation

Training

Compliance

Regulations

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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