HireDiversity

Cornelia, GA, US

Senior Quality Engineer-8383121029

Description

Medical Devices & Diagnostics Global Services, L.L.C., Global Supply Chain organization is recruiting for a Senior Quality Engineer, to be located in Cornelia, GA (approximately one hour from the Greater Atlanta area).

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.

Ethicon, Inc. 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. 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 Senior 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. 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 Senior 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.

Qualifications


A minimum of a Bachelor's degree is required, preferably in Engineering, a Life Science, a Physical Science, Chemistry, or Business. A minimum of 4 years of prior work experience in a Quality function is required. Certified Quality Engineer (CQE) (ASQ or equivalent) is preferred. Process Excellence Certification, such as Six Sigma, Lean or Quality by Design Green Belt or Black Belt, is 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 are 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 is preferred. Knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook) required. Experience with Minitab, Visio and Microsoft Project is preferred. Effective technical writing skills are required. Knowledge of general statistics is 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 located in Cornelia, GA (approximately one hour from the Greater Atlanta area).

BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-Georgia-Cornelia
Organization: Ethicon Inc. (6045)
Relocation: Eligible
Yes - Within Country