Senior Quality Engineer Job in Cornelia, Georgia Us
Ethicon, Inc, a Johnson Johnson Company is recruiting a Senior Quality Engineer, to be located in Cornelia, GA
Ethicon, Inc., a Johnson Johnson company, is a trusted, world-wide leader in surgical care. For over a century, Ethicon has continuously introduced innovations in wound closure, general surgery, wound management, women's health and urology and aesthetic medicine that fulfill the company's vision: Restoration of Body and of Life.
The Senior Quality Engineer will utilize Quality Engineering tools for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle. She/he 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. This individual will ensure effective risk management to prevent unanticipated failure modes and ensure capability.
The Senior Quality Engineer will function as a project team member in matters relating to Quality Engineering. She/he will 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. 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. She/he will ensure the development and validation of appropriate test methods for product and process performance. She/he will ensure effective and consistent application of Quality Engineering and PE tools and techniques. Additionally, this individual will ensure active and thorough investigation of quality issues and effective corrective and/or preventive action.
The Senior Quality Engineer will effectively utilize Process Excellence to solve problems and develop optimal products and processes. She/he will ensure compliance with company policies and procedures. She/he will provide guidance and recommendations involving the implementation of regulatory requirements (e.g., Quality System Regulation, EU MDD, ISO standards, etc.). This individual will 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 any changes in design or changes in process that could affect product design.
Qualifications
A minimum, BA/BS degree is required. A focused degree in Engineering, a Life Science, Physical Science, Chemistry, or Business preferred. A minimum of 4 years relevant business experience is required. A Certified Quality Engineer (ASQ or equivalent) is preferred. Process excellence certification such as Six Sigma, Lean or Quality by Design Green Belt or Black Belt is preferred. Demonstrated knowledge and application of QSR - 21CFR820, MDD, ISO-13485 ISO-14971 and other international standards are preferred. Experience with geometric Dimensioning and Tolerancing are preferred. Excellent PC skills including experience with Word, Excel, and PowerPoint are required. Experience with Minitab, Visio, Project are preferred. Effective technical writing is required. Excellent communication and interpersonal skills are required. Knowledge of general statistics and analytical problem solving is required. Knowledge of Lean Manufacturing and Manufacturing processes such as Just in Time, KANBAN and Pull Systems are preferred. This position is located in Cornelia, GA and requires minimal travel.
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