Quality Engineer Ii

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued, and our people can reach their potential.At Johnson & Johnson, we all belong.We are searching for the best talent for Quality Engineer II to be in Independencia.Purpose:Under the direction of Quality Operations Lead 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 as failure investigation and data analysis, 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.The Quality Engineer conducts assignments encompassing complete projects or portions of major projects. They determine methods and techniques to be used or adapt standard methods to meet variations. They coordinate phases of work internally and externally.You will be responsible for: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 others.Product Quality, Control & Disposition and Performance Standards- Conduct investigation, bounding, documentation, review and approval of nonconformances, 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 QualificationApprove 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- Develop control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.- Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.- Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.- Develop, interpret and implement standard and non-standard sampling plans- Assess effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis.- Assess and interpret common versus special cause variation in manufacturing processing and determine adequacy of current process limits.Risk Mitigation- Document, justify, review o