.At Johnson & Johnson Medical Devices Companies, we are using our breadth, scale, and experience to reimagine the way healthcare is delivered.In a radically changing environment, we are making connections across science and technology to combine our own expertise in surgery, orthopedics, and interventional solutions with the big ideas of others to design and deliver doctor and patient-centric products, solutions and help people live longer, healthier lives. And you can be part of it too. Whith Ethicon**Job Summary**Under the direction of Quality Operations Manager and with the objective of maintaining high quality standards for the product manufacturing process and compliance with regulatory requirements, administers Finished Goods Quality technicians and/or Quality Engineering technicians to support the Supply Chain including Project support, in day to day activities supporting manufacturing lines, operator certification program, incoming and finished good inspections, and CME environmental monitoring, all in accordance with applicable regulations and Ethicon written specifications and quality standards.**Responsibilities**May include, but are not limited to:Business Improvements- Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.- Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.- Conduct benchmarking with external companies or internal sites to develop more effective methods for improving quality- Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management.Compliance/Regulatory- Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc.- Champions compliance to applicable Global Regulations and standards (e.G. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.- Conduct periodic line audits to assess for production controls such as lot segregation. Review results of area audits to ensure that corrective and preventive actions are adequate.New Product/Process Introduction- Supports the development of quality strategies related to the transfer of products, materials and components within J&J or externally. Supports new product introduction as part of design transfer
