Quality Engineer Ii

**"Johnson & Johnson companies are equal opportunity employers"** At Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world. When You Join Johnson & Johnson, Your Move Could Mean Our Next Breakthrough. At Johnson & Johnson Medical Devices Companies, we are using our breadth, scale, and experience to reimagine the way healthcare is delivered and to help people live longer, healthier lives. 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 and solutions. We are in this for life. We are changing the trajectory of human health, YOU CAN TOO. **We are searching for the best talent for QUALITY ENGINEER II to be in JUAREZ.** **Purpose**:Under the direction of Quality Operations Managerand 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. **You will be responsible for**: Responsibilities may include, but are not limited to:The QualityEngineer utilizes Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle. The incumbent will also utilize Quality Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision. He/she will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes. This person will support processes in base business. 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. People - As applicable, provides supervision, mentoring, coaching, performance review, and developmental plans for othersProduct Quality, Control & Disposition and Performance Standards - Lead and maintain Material Review Board. - Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate. - Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process. - Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality. Product/Process Qualification. - Approve IQ, OQ, PQ, TMV or Software Validation. Production/Process Controls including Control Plans. - Conduct stakeholder analysis to ensure that customer CTQs are known and adequately addressed in control plan. - Develop measurement systems/capabilities, destructive tests, non-destructive tests for manufacturing processes. - Devel