Quality Engineer Job

Company Name:
J&J Family of Companies
Johnson & Johnson companies are equal opportunity employers.
Quality Engineer-7969140624
Ethicon, Inc., a member of the Medical Devices & Diagnostics Global Services, L.L.C., Global Supply Chain organization, within Johnson & Johnson's Family of Companies, is recruiting for a Quality Engineer, to be located in Cornelia, GA. Light travel may be required, based on business needs.
Medical Devices & Diagnostics (MD&D;) Global Services, L.L.C., represents more than 60 manufacturing sites and 26,000 employees who plan, source, manufacture and deliver high-quality and cost-effective medical products to our customers around the globe each day. Work of the MD&D; Supply Chain supports a multitude of product platforms, new products and delivery systems that are used in a wide range of procedures throughout the healthcare industry, including interventional cardiology, electrophysiology, minimally invasive surgery, hospital sterilization, clinical laboratory testing, diabetes management, joint replacement surgery and vision care.
The Quality Engineer will utilize Quality Engineering tools for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle. This individual will utilize Quality Engineering principles and problem-solving skills to develop and optimize products/processes that are aligned with the overall Quality and Business vision. Ensure effective risk management to prevent unanticipated failure modes and ensure capability.
The Quality Engineer will function as a project team member in matters relating to Quality Engineering. Ensure effective and efficient use of Quality Engineering techniques such as risk analysis, test method development, statistical data analysis, statistical process control, and development of sample plans using statistical sampling rational. This individual will ensure the development of a comprehensive risk management plan for the product and process. This individual will ensure effective quality strategies for validation. Ensure the development and validation of appropriate test methods for product and process performance. Ensure effective and consistent application of Quality Engineering and Process Excellence tools and techniques. Additionally, this individual will ensure active and thorough investigation of quality issues and effective corrective and/or preventive action.
The Quality Engineer will effectively utilize Process Excellence to solve problems and develop optimal products and processes. Ensure compliance with company policies and procedures. Provide guidance and recommendations involving the implementation of regulatory requirements (e.g. Quality System Regulations, EU MDD, ISO standards, etc.). Partner with Operations Engineering in the application of process validation, process control, and process risk management. Partner with Operations in the investigation/correction of process failures. Implement and monitor process capability for continuous improvement. Ensure effective change control and proactively communicate with DQE regarding any changes in design or changes in process that could affect product design.
A minimum of a Bachelor's degree is required, preferably in Engineering. A minimum of 4 years of prior work experience in a Quality function is required. Experience leading and/or facilitating Design of Experiments and Process Failure Modes Effects Analysis is preferred. Knowledge and application of QSR-21CFR820, Medical Device Directive (MDD), ISO 13485, ISO 14971 and other international standards are preferred. Experience with Geometric Dimensioning and Tolerancing is preferred. Knowledge of general statistics is required.
Knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook) is required. Experience with Minitab, Visio and Microsoft Project preferred. Knowledge of Process Excellence/Six Sigma tools and methodologies preferred. Knowledge of Lean Manufacturing and Manufacturing processes such as Just in Time (JIT), KANBAN and Pull Systems preferred. Process Excellence Certification, such as Six Sigma, Lean or Quality by Design Green Belt or Black Belt, is preferred. Certified Quality Engineer (CQE) (ASQ or equivalent) preferred. Effective technical writing skills required. Must have excellent communication and interpersonal skills. Must have strong analytical problem solving skills. The ability to collaborate with all levels of management in a cross-functional team environment is required.
This position will be based in Cornelia, GA. Light travel may be required, based on business needs.
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Primary Location: North America-United States-Georgia-Cornelia
Organization: Ethicon Inc. (6045)
Job Function: Quality (Eng)
Relocation: Eligible No
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Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
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Req ID: 7969140624
Date: Tue, 08 07 2014 00:00:00 GMT
Country: US
State: GA
City: Cornelia
Postal Code: 30531
Locale: en_US

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