The Ethicon Surgical Care business a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Senior 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 Senior Quality Engineer will be responsible for support and leadership of Quality Engineering activities in Life Cycle Engineering, New Product Development, CAPA, and process improvement activities for surgical instruments used in conjunction with surgical robotics systems. The quality engineering new product development has responsibility for Energy and Endomechanical in surgical instruments used on surgical robot systems.
• 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.
• Provide leadership, technical expertise to ensure conformance to ISO, FDA (Food & Drug Administration) & MDD (Medical Devices Directive) based quality systems,
• 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.
• A minimum of a bachelor’s degree is required. A degree in engineering or other equivalent technical degree is preferred. An advanced degree is an asset.
• A minimum of 5 years of experience in medical device, pharma or another highly regulated industry is required.
• Knowledge of Quality Engineering/Scientific methods and techniques is required.
• Experience with Risk Management (ISO 14971), Gage repeatability and reproducibility theory and application, statistics, project management (supporting multiple projects simultaneously), and reliability is preferred.
• ASQ certification (CQE, CQM, CRE, CQA) is an asset.
• Six Sigma Green Belt, Black Belt, or Master Black Belt certification is an asset.
• Knowledge of Regulatory compliance: GMP, MDD (Medical Devices Directive), 510K (Pre-market Notification), PMA (Pre-market Approval), and Government, trade association, industry & medical publications is preferred.
• Auditing skills such as - ISO, QSR (Quality Systems Regulations) and GMP standards is as asset.
This position will be located in Cincinnati, OH and will have up to 25% travel both domestically and internationally.
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