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GE HealthCare · 1 day ago

Quality Assurance Lead Engineer

Waukesha, WI

Full-time

Onsite

Mid, Senior Level

3+ years exp

GE HealthCare is a leading global medical technology and digital solutions innovator. The Quality Assurance Lead Engineer is responsible for providing engineering processes and QMS management support, ensuring quality and regulatory compliance while driving process effectiveness and efficiency in the Diagnostic Cardiology business segment.

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Growth Opportunities

No H1B

U.S. Citizen Only

Responsibilities

Creates a Quality culture by driving compliance activities around a specific product, site or region. This includes being responsible for the total quality management system for the business and driving Quality metrics

Ensures quality and regulatory compliance while driving process effectiveness and efficiency

Represents GE Healthcare to external agencies and champions the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting and operating mechanisms

Developing in-depth knowledge of a discipline

Uses prior experience and acquired expertise to execute functional policy/strategy

A job at this level is likely to be an individual contributor, with proven interpersonal skills

Communication with direct colleagues and the business about design and coordination services rendered

Provides informal guidance to new team members

Explains complex information to others in straightforward situations

Impacts projects, processes, and procedures in own field

The role operates with some autonomy but is focused on execution of activities/provision of advice within an enabling discipline covered by standard functional practices and procedures

Activities require professional judgment but may require more senior levels of guidance

Utilizes technical expertise and judgement to solve problems

Leverages technical skills and analytic thinking required to solve problems

May use multiple internal sources outside of own team to arrive at decisions

Qualification

Quality Management SystemMedical Device QMSRegulatory ComplianceContinuous ImprovementAnalytical SkillsCommunication SkillsProblem SolvingLeadership SkillsCollaboration Skills

Required

Bachelor's degree in an engineering or technical discipline; OR High School Diploma with a minimum 7 years of experience in manufacturing, engineering, or quality assurance

Minimum 3 years of experience working in a regulated industry

Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485

Legal authorization to work in the U.S. is required. We will not sponsor individuals for employment visas, now or in the future, for this job opening

Preferred

Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes

Demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, manufacturing / production process control methodologies, and servicing in a medical device environment

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 improvement using tools such as six sigma, DFR, etc

Demonstrated collaboration, negotiation & conflict resolution skills

Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy to ensure compliance

Excellent oral communication & report, business correspondence & procedure-writing skills

Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance

Change agent with energy, passion & enthusiasm to drive change

Exceptional analytical, problem solving & root-cause analysis skills

Ability to multi-task & handle tasks with competing priorities effectively

External Focus: Understanding customer needs, marketplace dynamics, industry trends, & the competitive landscape in the industry/function & considering the external impact of business activities & decisions on the external environment

Clear thinker: Simplifying strategy into specific actions with clear accountability, making decisions with speed & accuracy based on best available information & communicating priorities clearly & concisely

Benefits

Great work environment

Professional development

Challenging careers

Competitive compensation

Company

GE HealthCare

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GE Healthcare provides a wide range of medical technologies and services to healthcare providers and researchers. It is a sub-organization of General Electric.

Founded in 1892

Chicago, Illinois, USA

10001+ employees