Quality Operation Engineer

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.comJob FunctionQualityJob Sub FunctionQuality AssuranceJob CategoryProfessionalAll Job Posting Locations:Ringaskiddy, Cork, IrelandJob DescriptionAbout OrthopaedicsFuelled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.Are you passionate about improving and expanding the possibilities of Orthopaedics? Ready to join a team that’s reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery.Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtechDepuy are looking for a Quality Operation Engineer to be based at the Cork, Ireland site.As a Quality Operations Engineer You WillConduct 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 utilize 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.Key ResponsibilitiesBusiness Improvements: Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management.Compliance/RegulatoryReview/analyse whether current product and processes (including actions or decisions conducted) comply to standards such as the QSRs, ISO 13485, etc. Appendix I 100612422 Rev M CONFIDENTIAL use pursuant to Company Procedures.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.Product Quality, Control & Disposition And Performance StandardsSupports activities related to the Material Review Board.Conduct investigation, bounding, documentation, review and approval of non-conformances, 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.Analyse/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.Production/Process Controls Including Control PlansInvestigation/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 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 plansRisk Mitigation: Document, justify, review or analyse 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.Strategic: Ensures effective quality strategies are created for the validation of test methods, process and design.Experience, Skills & Proficiencies RequiredA 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 relevant experience working in manufacturing/operations.Experience with a proven track record of implementing appropriate risk mitigation.The ability to perform "hands on" troubleshooting and problem solving is preferred. The ability to think on the feet and providing sound judgment is highly desired.Here’s What You Can ExpectApplication review: We’ll carefully review your CV to see how your skills and experience align with the role.Getting to know you: If there’s a good match, you’ll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.Staying informed: We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.Final steps: For successful candidates, you will need to complete country-specific checks before starting your new role. We will help guide you through these.Finally, at the end of the process, we’ll invite you to share feedback in a short survey — your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. We’re excited to learn more about you and wish you the best of luck in the process!Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals.Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processesRequired SkillsPreferred Skills: