Quality Assurance Lead Engineer

GE HealthCare; Waukesha (WI); Híbrido; USD 110.000 - 140.000; Jornada completa

Descripción de la vacante

GE HealthCare is seeking an experienced Quality Assurance professional in Wisconsin to lead engineering processes and QMS management for the Patient Care Solutions business. This role focuses on design, design transfer, deployment of the QMS, and continuous improvement to ensure regulatory readiness and product quality.

The ideal candidate has a technical background, at least 3 years in a regulated environment, and strong collaboration skills to partner with global teams while maintaining high

Formación

• Bachelor’s degree in engineering or technical field or equivalent experience.
• Experience in regulated manufacturing/quality environments.
• Familiarity with FDA CFR 21 820 and ISO 13485.

Responsabilidades

• Drive quality culture and total quality management across product/site/region.
• Ensure regulatory compliance and improve process effectiveness.
• Represent GE Healthcare to external agencies and lead quality objectives.
• Develop domain expertise and apply policy/strategy to tasks.
• Communicate design controls, CAPA, and risk management to teams.

Conocimientos

Quality Assurance

Regulatory compliance

Cross-functional collaboration

Educación

Bachelor’s degree in engineering or technical discipline

High School Diploma with 7 years experience

Herramientas

QMS

Descripción del empleo

Job Description Summary

This position is responsible for providing engineering processes and QMS management support in accordance with documented procedures and practices. This is a key technical/management role responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the local business, including areas of design, design transfer, and deployment of the QMS for the Patient Care Solutions business.

Job Description Summary

This position is responsible for providing engineering processes and QMS management support in accordance with documented procedures and practices. This is a key technical/management role responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the local business, including areas of design, design transfer, and deployment of the QMS for the Patient Care Solutions business.

GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

Roles and 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.

Required Qualifications

• 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.
• Willingness to work a hybrid schedule with three days per week on-site at the GE HealthCare office located in Waukesha, Wisconsin
• Demonstrated flexibility in approach to work hours, and willingness to partner with and accommodate global teams and schedules

Desired Characteristics

• 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.

We will not sponsor individuals for employment visas, now or in the future, for this job opening.

Additional Information

GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

GE HealthCare 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).

While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.

Relocation Assistance Provided: No