Lead Quality Analyst at GE Healthcare

Arlington Heights, Illinois, 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

Pharmaceutical, Medical Device, HealthcareIndustries

Requirements

Bachelor's degree (or high school diploma/GED plus 7 years experience in a QA/RA or medical device/pharmaceutical environment)
3+ years of experience in a pharmaceutical OR medical device industry
Thorough familiarity with cGMPs of sterile product manufacture
Must be willing to perform weekend work on a rotating schedule

Responsibilities

Liaising with Operations personnel to ensure regulatory and quality requirements are met during routine operations
Participating in audits, together with follow up (including internal audits as well as external/Supplier audits)
Conducting QA activities including revision of SOPs, SAP QA work and the issuance of protocols
Responsible for review of batch records and the release of all products, including Raw Material batches
Responsible for the review of Non-Conformances related to product manufacture/testing
Responsible for performing investigations arising from product complaints
Gathering and reporting metrics as required by the business
Provide Quality Assurance support for implementation of new products at the site
Support global QA initiatives as determined by the business

Skills

Key technologies and capabilities for this role

cGMPQAAuditsSOPBatch RecordsProduct ReleaseCAPAComplaint HandlingNon-ConformancesInvestigations

Questions & Answers

Common questions about this position

What is the salary range for this Lead Quality Analyst position?

This information is not specified in the job description.

Is this position remote or onsite?

This is an onsite position.

What qualifications and experience are required for this role?

A Bachelor's degree (or high school diploma/GED plus 7 years experience in a QA/RA or medical device/pharmaceutical environment), 3+ years of experience in a pharmaceutical or medical device industry, and thorough familiarity with cGMPs of sterile product manufacture are required.

What is the company culture like at GE HealthCare?

GE HealthCare fosters a culture where every voice makes a difference, emphasizing behaviors like acting with humility and building trust, leading with transparency, delivering with focus, driving ownership with integrity, and promoting care, collaboration, and support.

What makes a strong candidate for this Lead Quality Analyst role?

Strong candidates will have the required qualifications plus desired characteristics like 1+ year of experience with CAPA systems, analytical and problem-solving skills, excellent communication, statistics training, Continuous Improvement knowledge such as Six Sigma, teamwork skills, multitasking ability, and prior GE HealthCare experience.

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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