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Lead Quality Engineer- Cell Analysis job

GE HealthcareIssaquah, WA
GE Healthcare jobs

Company

Company Description

GE Healthcare is a multinational conglomerate firm that produces medical equipment. The firm offers monitors, scanners, dispensers, displays, imagers, recorders, analyzers, separators, and medical and laboratory medical equipment for medical industries. GE Healthcare provides transformational medical technologies that are shaping a new age of patient care. The company's broad expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, biopharmaceutical manufacturing technologies, drug discovery, performance improvement, and performance solutions services help its customers deliver better care to more people worldwide at an affordable price. GE Healthcare was founded in 1994, and its headquarter is based in Chicago, Illinois, United States. The company partner with healthcare leaders who strive to leverage the global policy change required to successfully shift to sustainable healthcare systems. GE Healthcare provides healthcare benefits and other perks to its employees.

Job Description

manufacturing, R&D engineering, and service support in accordance with
documented procedures & general practices. This is a key technical role
responsible for the development, implementation, maintenance, improvement and
continuous reinforcement of established Quality Assurance fundamental practices
and Quality Management System procedures sed in the local business.
Essential Responsibilities:This role involves hands-on work in the areas of
design, design transfer, manufacturing, distribution, and service.
Assists in ensuring 100 percent quality and regulatory compliance in accordance
with documented procedures for all aspects of functional responsibility
Responsible for the development, implementation, and continuous improvement of
quality system process effectiveness and efficiency
Assumes process owner responsibilities for select Quality Management System
processes (may include MRB, Training, Deviations/Concession, NPI, Audits,
Nonconformance Investigations, CAPA, Calibration, Complaints, etc.) which
includes process definition, process coordination, trending of key performance
metrics, training, streamlining, or other support activities
Supports risk management in accordance with documented procedures which may
include PFMEA, DFMEA, Fault Tree Analysis, Failure Mode Analysis, etc.
Responsible for supporting planning and deployment of field actions
Conducts internal audits (ISO 9001 QMS) and supports external audits
Identifies and influences continuous product and process improvement through
detailed quality data trending, failure analysis and investigations into non-
conformances
Supports development and implementation of effective and compliant solutions
for product or process corrections and for corrective and preventive actions
(CAPA Program)
Provides coaching to other members of the QAQC team
Qualifications/Requirements:
Bachelor's Degree in Engineering (or other technical discipline) or a minimum
of 8 years work experience
Minimum of 3-5 years experience working in a regulated industry or experience
working in an ISO 9001 compliant quality system
Exceptional analytical, problem solving & root-cause analysis skills
Ability to communicate effectively in English (both written and oral)
Ability to present quality related topics to cross functional teams and senior
management
Ability to lead cross functional teams to resolve quality related issues
Demonstrated experience and proficiency with MS Office suite
Demonstrated collaboration & conflict resolution skills
Experience managing multiple projects and priorities
Desired Characteristics:
Minimum of 3 years working in a regulated medical device or pharmaceutical
industry
Demonstrated experience and proficiency working with applications for flow
charts, statistic packages and relational databases
Demonstrated experience and proficiency working with PLM systems, electronic
quality systems (CAPA, Training, MRB), ERP systems, etc.
Demonstrated expertise to effectively communicate within all levels of the
organization around concepts of design controls, design verification and
validation activities; production &process controls; Corrective & Preventive
Action (CAPA), complaints & risk management; & product quality
Experience performing internal and external audits
Experience leading and implementing change
About Us:GE (NYSE:GE) drives the world forward by tackling its biggest
challenges. By combining world-class engineering with software and analytics,
GE helps the world work more efficiently, reliably, and safely. GE people are
global, diverse and dedicated, operating with the highest integrity and passion
to fulfill GE s mission and deliver for our customers.
GE offers a great work environment, professional development, challenging
careers, and competitive compensation. GE is an Equal Opportunity Employer .
Employment decisions are made without regard to race, color, religion, national
or ethnic origin, gender (including pregnancy), sexual orientation, gender
identity or expression, age, disability, veteran status or any other
characteristics protected by law.
Additional Eligibility Qualifications:GE will only employ those who are legally
authorized to work in the United States for this opening. Any offer of
employment is conditioned upon the successful completion of a drug screen (as
applicable).Additional Locations:United States;Washington;Issaquah;

GE Healthcare

Type

Subsidiary

Size

Large

Revenue

Over $10B

Location

Multiple locations

Industry

Pharmaceutical Manufacturers
Pharmaceuticals

Founded

1892

CEO

John L. Flannery

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