The Ethicon Surgical Care business a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Staff Quality Engineer located in Cincinnati, OH.
The Ethicon Surgical Care business offers a broad range of products, platforms and technologies—including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices—that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women’s health conditions, hernias, cancer and obesity. The Ethicon Surgical Care business combines products and services of two market leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and electiveness of open surgery. Ethicon Endo-Surgery, Inc. was created 20 years ago in Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today.
The Staff Quality Engineer will be responsible for support and leadership of Quality Engineering activities in Life Cycle Engineering, New Product Development/ Process Introduction, and Business Improvement activities.
• Responsibilities will be to provide leadership in design & implementation of world-class quality engineering to support entire product life cycle with focus on quality engineering activities such as reliability, risk management, analytics/statistical techniques, requirements management, verification & validation, and design control across the lifecycle of the product. Activities would drive prevention, detection of defects at earliest phase of product design, continuous improvement & customer satisfaction. Particular focus will be in driving quality engineering activities in development and maintenance of software for medical electrical systems.
• Provide leadership, technical expertise to ensure conformance to ISO, FDA (Food & Drug Administration) & MDD (Medical Devices Directive) based quality systems, Support global product registration needs by acting as liaison for technical questions in the areas of product testing as it pertains to design control and compliance to external standard, such as the IEC 60601 series of standards.
• Provide review and approval for the release of new products ensuring quality requirements are met provide leadership & support to J&J process excellence initiatives including Six-sigma, design excellence & lean thinking.
• Direct development & consistent application of quality policies & procedures in product design & development, secondary development & transfer operations.
• Act as technical liaison, as needed, between product development, manufacturing, external manufacturers & suppliers. Qualifications
• A minimum of a Bachelor's degree is required, a degree concentration in Engineering, Life Science, Physical Science or a related field is preferred; an advanced degree is an asset.
• A minimum of 6-8 years of experience of related work experience is required. Experience in the medical device industry is strongly preferred. Experience with medical electrical-mechanical systems an asset.
• Experience in statistical methods, and data analysis required. Knowledge of Good Manufacturing Practices (GMPs) and ISO policy and procedures is preferred.
• Knowledge of FDA requirements for design control of medical devices, particularly with verification and validation of software for medical electrical equipment, an asset.
• Experience driving risk management discussions, particularly as it relates to cascading identified product issues/hazards into potential user harms.
• Demonstrated Project management skills, such as supporting multiple projects simultaneously are required.
• Reliability test method development, planning, and execution an asset.
• Experience with medical electrical safety standards (such as the IEC 60601 series of standards) preferred.
• An ASQ certification (CQE, CQM, CRE or CQA) is an asset. Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is an asset.
• This position will be located in Cincinnati, OH and will have up to 10% travel both domestic and international.
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Ethicon Endo Surgery Inc (6041)Job Function
Quality (Eng)Requisition ID
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