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.
Design Quality Engineer
Salt Lake City, UT 84116
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Role Summary : This position is responsible for providing design engineering process support in accordance with documented procedures and practices. This is a key technical role responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the local business. The role involves hands-on work in the areas of design controls, design transfer, distribution, and/or service.
Assists in ensuring 100 percent quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility.
Leads, acknowledges, develops, communicates & implements a strategy to ensure compliance.
Responsible for the development, implementation, and continuous improvement of process effectiveness and efficiency at the site.
Develops process improvement plans using a variety of Quality and Continuous Process Improvement tools, including but not limited to Six Sigma, engineering studies, DOE, Gauge R & R, etc.
Leads process efficiency and compliance effectiveness through the development and implementation of process verification and validation plans, including Master Validation Plans (Site Level), Validation Master Plans (Product or Process specific plans), and the development of detailed process flow diagrams that describe critical process interdependencies with respect to process inputs, outputs, risks and impacts.
Supports continuous product and process improvement through detailed failure analysis for non-conformances, and investigates, develops and implements effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions (CAPA Program).
Utilizes risk management tools and aids for use by the organization in accordance with documented procedures, including but not limited to PFMEA, DFMEA, Fault Tree Analysis, Failure Mode Analysis, etc. Supports design mitigation efforts. Develops process mitigation plans and strategies that are designed to mitigate the risks identified through the Risk Management process.
Ensures process compliance through the development of comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation.
If managing a team, provides guidance and facilitates problem resolution, resource utilization, career counseling, coaching and mentoring of team members as applicable.
Performs a broad variety of tasks in support of product and process design as assigned by the departmental manager.
Bachelor Degree or a minimum of 4 years work experience.
Minimum of 1 year experience working in a regulated industry or a Masters degree
Ability to communicate effectively in English (both written and oral).
Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications.
Minimum of 3 years experience in a regulated industry is preferred
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.
Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes
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
Excellent communication skills (written and oral)
Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance
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 understanding of continuous quality / process improvement tools: (As defined by the local site, e.g. DMIAC, SPC, Lean SS, 5S)
Experience leading and implementing change
Experience performing internal audits and participating in external audits
Exceptional analytical, problem solving & root-cause analysis skills
Ability to multi-task & handle tasks with competing priorities effectively
Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & demonstrated experience interfacing with regulators.
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).
United States;Utah;Salt Lake City;
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