Quality Operations Engineer

Role: Quality Operations Engineer Location: Cork, Ireland Reports to: Quality Operations Team Lead Closing Date: 21st January 2022 Introduction: For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we in Ireland are working to build an inclusive environment where a diverse set of backgrounds, perspectives and experiences are valued and each and every one of our people feel that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”! Description DePuy Synthes, Companies of Johnson & Johnson, is the largest, most comprehensive orthopedic and neurological business in the world, built upon the strong legacies of two phenomenal companies. DePuy Synthes offer an unparalleled breadth and depth of technology, devices, services and programs in joint reconstruction, trauma, spine, sports medicine, neurological, cranio-maxillofacial, power tools and biomaterials. Our broad array of inspired, innovative and high-quality offerings helps advance the health and wellbeing of people around the world. DePuy Synthes, who employ over 1000 people in Cork established its manufacturing facility in Cork in 1997 where it manufactures orthopedic knees and hips. In 2014, DePuy Synthes in Cork won the Shingo Prize for Operational Excellence. Overall responsibilities: 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. The Quality Engineer will apply 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 apply Quality Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision. The successful candidate will use appropriate risk management to prevent unanticipated failure modes and improve capability of processes. This person will support processes in base business. Position duties & responsibilities: 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 to develop more effective methods for improving quality Supports the development of quality engineering and quality compliance with the right abilities for new product introductions, and product life cycle management. Compliance/Regulatory Review/analyze whether current product and processes (including actions or decisions conducted) comply 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 Partners with R&D and other multi-functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges. Supports new product introduction as part of design transfer. Product Quality, Control & Disposition and Performance Standards Supports activities related to the Material Review Board. Conduct investigation, bounding, documentation, review and approval of nonconformances, CAPAs and customer complaints. Escalation of quality issues as appropriate. Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing. 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 Partners with J&J Global Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management; and the investigation/correction of process failures when needed. Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk. Collect data and implement/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 or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine effectiveness of these techniques on previously implemented improvements Strategic Ensures effective quality strategies are created for the validation of test methods, process and design.
INDHP Qualifications Education & experience requirements: A minimum of a Bachelor’s Degree, preferably in Engineering or related technical field. Generally, requires 2-4 years related experience. Experience working in both an FDA and European regulatory environment is preferred. This position will require proven experience working in manufacturing/operations. In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required. Experience with a proven track record of implementing appropriate risk mitigation. Solid understanding of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making. Good technical understanding of manufacturing equipment and processes is required. Desirable: Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc. The ability to perform