QA Supervisor at GE Healthcare

Shanghai, Shanghai, China

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Pharmaceuticals, Medical DevicesIndustries

Requirements

B.S. Degree in technical field, preferably in pharmacy, food science, chemistry, etc
Minimum 5-year experience in pharmaceutical industry or medical device; experience in QA or QC preferred
Thorough knowledge of national and international GMP requirements
Fluent English in speaking, listening, reading, and writing
Proficiency in Microsoft Office Suite

Responsibilities

Lead QA on-site inspection related activities including monitoring manufacturing process/documentation/computerized systems to meet procedures, GMP, and data integrity requirements
Solve on-site manufacturing issues from QA perspective and ensure processes meet standard operating procedures
Lead/follow/approve on-site inspection related deviations/investigations/CAPAs to ensure compliance with cGMP
Liaise with Operations department/personnel to ensure regulatory and quality requirements are met, enhance compliance awareness, and standardize operations
Lead cross-department/site/Kaizen projects to ensure they run smoothly against schedule
Review and approve related documentations including SOPs, specifications, manufacturing processes, etc
Participate in internal and external audits, handle audit responses, and implement improvements
Supervise subordinates including coaching and development

Skills

GMP

cGMP

QA Inspection

Deviation Management

CAPA

Data Integrity

SOP Review

Audit Management

Kaizen

Manufacturing Process

Pharmaceutical QA

Medical Device QA

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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