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Position Title: Quality Operations Engineer Location: Cork, Ireland Reporting to: Quality Operations Team Lead Band: 24 About the Company: DePuy Synthes, a Johnson & Johnson company, stands as the world's leading orthopedic and neurological business, merging the legacies of two esteemed companies.
With a comprehensive range of technologies, devices, and services spanning joint reconstruction, trauma, spine, sports medicine, and more, we're dedicated to advancing global health and well-being. Established in Cork since 1997, DePuy Synthes proudly manufactures orthopedic knees and hips, with a workforce exceeding 1000 employees.
In 2014, our Cork facility was honored with the prestigious Shingo Prize for Operational Excellence. Position Overview: As a Quality Operations Engineer, you'll lead and contribute to key projects, ensuring adherence to quality standards throughout the product lifecycle.
Collaborating internally and externally, you'll employ Quality Engineering principles to enhance processes and products, aligning with our overarching quality and business objectives. Key Responsibilities: Business Improvements: * Spearhead quality improvement initiatives to drive continuous enhancements and cost efficiencies. * Evaluate and implement methodologies like PDCA, Six Sigma, and Lean Techniques. * Conduct benchmarking to refine quality enhancement methods. * Support the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management. Compliance and Regulatory Affairs: * Ensure compliance with industry standards such as QSRs, ISO 13485, etc. • Champion adherence to global regulations and standards (e.g.
QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits. • Perform 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: * Collaborate with R&D to ensure compliance with design controls and risk management protocols. * Support seamless integration of new products into manufacturing processes. Product Quality, Control & Performance Standards: * Support 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 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. 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.
Qualifications: * Bachelor's Degree in Engineering or related technical field. * 2-4 years of relevant experience, preferably in an FDA and European regulatory environment. * This position will require relevant 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. * Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc. * Strong knowledge 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. * 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. * Good technical understanding of manufacturing equipment and processes is required. * Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred. * A thorough understanding of GMP/ISO regulations and validation regulations is preferred. * Advanced knowledge and experience in the areas listed in the Duties and Responsibilities associated with the position. * Demonstrated project management and project leadership abilities are preferred. * Proficiency in product/process Risk Management and statistical methodologies. * Strong understanding of manufacturing processes and equipment. * Familiarity with GMP/ISO regulations and validation protocols. * Demonstrated project management and leadership skills. Additional Details: * This position is fully onsite. Join Our Team: If you're driven by a passion for excellence and seek to make a meaningful impact in healthcare, we encourage you to explore opportunities within the Johnson & Johnson Talent Community at www.careers.jnj.com . Equal Opportunity Employer: We are committed to fostering an inclusive workplace and do not discriminate based on race, religion, gender, or any other factor.
Join us in shaping the future of healthcare with your unique talents and perspectives.
With a comprehensive range of technologies, devices, and services spanning joint reconstruction, trauma, spine, sports medicine, and more, we're dedicated to advancing global health and well-being. Established in Cork since 1997, DePuy Synthes proudly manufactures orthopedic knees and hips, with a workforce exceeding 1000 employees.
In 2014, our Cork facility was honored with the prestigious Shingo Prize for Operational Excellence. Position Overview: As a Quality Operations Engineer, you'll lead and contribute to key projects, ensuring adherence to quality standards throughout the product lifecycle.
Collaborating internally and externally, you'll employ Quality Engineering principles to enhance processes and products, aligning with our overarching quality and business objectives. Key Responsibilities: Business Improvements: * Spearhead quality improvement initiatives to drive continuous enhancements and cost efficiencies. * Evaluate and implement methodologies like PDCA, Six Sigma, and Lean Techniques. * Conduct benchmarking to refine quality enhancement methods. * Support the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management. Compliance and Regulatory Affairs: * Ensure compliance with industry standards such as QSRs, ISO 13485, etc. • Champion adherence to global regulations and standards (e.g.
QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits. • Perform 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: * Collaborate with R&D to ensure compliance with design controls and risk management protocols. * Support seamless integration of new products into manufacturing processes. Product Quality, Control & Performance Standards: * Support 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 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. 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.
Qualifications: * Bachelor's Degree in Engineering or related technical field. * 2-4 years of relevant experience, preferably in an FDA and European regulatory environment. * This position will require relevant 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. * Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc. * Strong knowledge 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. * 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. * Good technical understanding of manufacturing equipment and processes is required. * Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred. * A thorough understanding of GMP/ISO regulations and validation regulations is preferred. * Advanced knowledge and experience in the areas listed in the Duties and Responsibilities associated with the position. * Demonstrated project management and project leadership abilities are preferred. * Proficiency in product/process Risk Management and statistical methodologies. * Strong understanding of manufacturing processes and equipment. * Familiarity with GMP/ISO regulations and validation protocols. * Demonstrated project management and leadership skills. Additional Details: * This position is fully onsite. Join Our Team: If you're driven by a passion for excellence and seek to make a meaningful impact in healthcare, we encourage you to explore opportunities within the Johnson & Johnson Talent Community at www.careers.jnj.com . Equal Opportunity Employer: We are committed to fostering an inclusive workplace and do not discriminate based on race, religion, gender, or any other factor.
Join us in shaping the future of healthcare with your unique talents and perspectives.