10 days old

QA Lead Engineer

GE Energy
Noblesville, IN 46060
**Job Description Summary**

GE Healthcare is a medical technology and diagnostics business with a vision to become the leading innovator enabling precision health. With us, you can touch the lives of thousands of people globally and make every moment matter in your career. This position is a Project Leader for Quality and is responsible for providing manufacturing and/or 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, design transfer, manufacturing, distribution, and/or service.



**Job Description**



**Essential Responsibilities:**



+ 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), the creation of device history record contents, and the development of detailed process flow diagrams that describe critical process interdependencies with respect to process inputs, outputs, risks and impacts.

+ 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, Lean Manufacturing, 5S, SPC, engineering studies, DOE, Gauge R&R, etc.

+ 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.



**Qualifications/Requirements:**



+ Bachelor's 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.



**Desired Characteristics:**



+ 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 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 expertise to effectively communicate within all levels of the organization around concepts of production &process controls including equipment qualification and process validation; 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)

+ Experience leading and implementing change.

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

+ Demonstrated understanding of continuous quality / process improvement tools: (As defined by the local site, e.g. DMIAC, SPC, Lean SS, 5S)

+ Exceptional analytical, problem solving & root-cause analysis skills

+ Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & demonstrated experience interfacing with regulators. Experience performing internal audits and participating in external audits



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).



GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer at https://assets.phenompeople.com/CareerConnectResources/GE11GLOBAL/en_global/desktop/assets/images/poster_screen_reader_optimized_w_supplement.pdf . at http://www.ge.com/sites/default/files/15-000845%20EEO%20combined.pdf 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 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).



**Relocation Assistance Provided:** Yes

Categories

Posted: 2020-11-18 Expires: 2020-12-18

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QA Lead Engineer

GE Energy
Noblesville, IN 46060

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