GE HealthCare · 2 days ago
Lead Quality Specialist - Business Process Management
Arlington Heights, IL
Full-time
Onsite
Senior Level
$117K/yr - $176K/yr
5+ years expGE HealthCare is a leading global medical technology and digital solutions innovator. The Lead Quality Specialist will provide direct oversight for pharmaceutical manufacturing operations, conduct product releases, and facilitate continuous improvement while working in a cross-functional team environment.
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No H1B
Responsibilities
Liaising with Operations personnel to ensure regulatory and quality requirements are met during routine operations
Participating in audits, together with follow up. This includes 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 and/or 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
Responsible for PET QA distribution activities, ensuring compliance with applicable regulatory and quality requirements
Deliver PET QA distribution activities to established timelines, ensuring efficient execution and issue resolution
Develop, track, and present metrics related to PET QA distribution performance to support business objectives and continuous improvement
Collaborate cross-functionally across multiple functions and sites to align quality objectives and influence outcomes
Exercise independent judgment in day-to-day quality decisions, while recognizing and appropriately escalating issues that may impact product quality, compliance, or patient safety
Qualification
Required
Bachelor's degree (or high school diploma/GED plus 9 years experience in a QA/RA or medical device/pharmaceutical environment)
5+ 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
Preferred
Experience with CAPA systems, including complaint handling
Analytical & problem-solving skills/root-cause analysis
Excellent oral and written communication skills
Statistics education and or training
Experience developing and tracking quality metrics
Familiar with Continuous Improvement methodologies, including Six Sigma
Demonstrated effective interpersonal and effective teamwork skills
Ability to effectively multi-task (i.e. effectively handle competing priorities)
Prior GE HealthCare experience
Benefits
Medical
Dental
Vision
Paid time off
A 401(k) plan with employee and company contribution opportunities
Life
Disability
Accident insurance
Tuition reimbursement
Company
GE HealthCare
GE Healthcare provides a wide range of medical technologies and services to healthcare providers and researchers. It is a sub-organization of General Electric.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$5.52BKey Investors
Bill & Melinda Gates Foundation
2024-11-07Post Ipo Secondary· $1.17B
2024-09-12Post Ipo Secondary· $1.29B
2024-02-16Post Ipo Secondary· $1.07B
Leadership Team
Catherine Estrampes
President and CEO, US & Canada
Luiz Verzegnassi
President & CEO, Services
Recent News
2026-01-16
Medical Device Network
2026-01-16
2026-01-16
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