Quality Leader PDx China at GE Healthcare

Shanghai, Shanghai, China

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, PharmaceuticalsIndustries

Requirements

Bachelor's Degree of Science (Pharmacy, Chemistry, Biology or Biochemistry)
Minimum of 5 years working in a regulated pharmaceutical and/or medical device industry
Minimum of 1 year supervisory/management or project leadership experience
Ability to communicate effectively in English and Spanish (both written and oral)
Demonstrated experience using word processing, spreadsheet, and presentation software
Demonstrated understanding or aptitude to understand Pharmaceutical and Medical Device QMS requirements and regulatory requirements including but not limited to MFDS (Ministry of Food and Drug Safety), FDA CFR 21 820, ISO 13485, Good Distribution Practices (GDP), Good Laboratory Practices

Responsibilities

Accountable for ensuring full quality and regulatory compliance of a facility with regulatory, GE and GDP requirements/regulations, while driving process effectiveness and efficiency at the site
Ensures site audit readiness and hosts the Quality System audits and inspections (internal, customer and regulatory); prepares and executes Quality Management System reviews
Maintains and improves all aspects of Site Quality Planning
Oversees all Quality-related communications and training requirements for all site employees
Maintains positive agency relationships-liaisons with regulatory agencies upon site inspections and participates in external technical forums
Oversees product testing and release procedure for distribution in the region. Closely works with testing laboratories and external GDP partners
Oversees the Corrective Action / Preventive Action activities and Complaint Handling Programs
Reports on Quality System effectiveness and requirements to management team as required including preparing and executing facility Quality Management Reviews
Drives the definition of site quality objectives, metrics, reporting and operating mechanisms
Owns site compliance assessment and remediation plans while influencing site execution, functional policy, local research and development programs, and communications and training requirements for Quality matters
Influences site compliance to Quality policy, Quality Management System procedures, and Quality Star guidelines
Influences quality system metrics such as Corrective and Preventive Action, training metrics, completion and complaint resolution metrics
If managing a team, provides leadership and facilitates problem resolution, resource utilization, career counseling, mentoring and development of team members
Participates in selected global initiatives to share best practices and leverage quality synergies
Supports local NPI programs and quality issue resolution
Acts as Management Representative for Quality at the Site
Supports audits and oversight of third party suppliers, distribution service providers (warehouses, transport, wholesaler/dealer, channel partners, etc.)
Maintains positive relationships-liaisons with customers, local distributors and other business partners

Skills

Key technologies and capabilities for this role

Quality ManagementRegulatory ComplianceGMPGDPAudit ManagementCAPAQuality SystemProcess ImprovementComplaint HandlingTrainingAgency Liaison

Questions & Answers

Common questions about this position

Is this a full-time position?

Yes, this is a full-time employment position.

Where is this role located?

The role is based in PDx China, with potential support for Hong Kong and other countries in Asea.

What are the key responsibilities for this Quality Leader role?

The role involves ensuring quality and regulatory compliance, driving process effectiveness, overseeing audits and inspections, managing corrective actions, and leading quality communications and training.

What is the company culture like at GE Healthcare?

GE Healthcare fosters an innovative environment where every voice makes a difference, emphasizing ambition, turning ideas into world-changing realities, and building a healthier world.

Does this role involve managing a team?

Yes, if managing a team, the role includes providing leadership, facilitating problem resolution, resource utilization, career counseling, mentoring, and development of team members.

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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