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JOB DESCRIPTION:

Depuy Ireland Unlimited Company is recruiting for a Quality Engineering Team Lead, located in Ringskiddy, Cork

• Leads team of Quality Engineers in the implementation of Quality Engineering tools and practices, with a view to risk mitigation and patient safety.
• Partner with cross functional teams to deliver NPI and Product/Process Transfers.
• Partners with 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.

EDUCATION:

• A minimum of a bachelor’s degree, preferably in Engineering or related technical field.
• 4-6 years related experience in a quality engineering role or 2+ years in a related Team Leadership position.
• Experience working in both an FDA and European regulatory environment is required.
• Requires relevant experience working in manufacturing/operations.

Qualification and Validation

• Reviews and approves IQ, OQ/PQ and CSV for manufacturing and test equipment
• Ensures the implementation of suitable measurement systems through the principles of MSA and analyse, review and approve that collected data is unbiased, reliable, and consistent e.g., Gauge Repeatability and Reproducibility
• Provides guidance on the analysis of sources of variation in measurement systems, with a view to control of variation.
• Ensures effective quality strategies are carried out for the validation of test methods, process and design.
• Support New Product Introduction (NPI) as part of design transfer and establishing process stability for NPI through the review, analysis and approval of implemented statistical process control activity and monitoring of process performance.
• Approval of change control of NPI changes for compliance to established standards, regulations and procedures.
• Support Product/Process Transfers and establishing process stability for transfers through the review, analysis and approval of implemented statistical process control activity and monitoring of process performance

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

Business Improvement and Quality Assurance

• Guide the implementation of Continuous Improvement, Quality Assurance and Performance through Lean, Six Sigma, Kaizen, PDCA.
• Review and analyse collected data for implemented/conducted analytical/statistical analyses and provide feedback as part of process improvements and day-to-day support.
• Review the effectiveness of continuous improvement tools and techniques and effectiveness of benchmarking conducted to improve quality. Participate and act as a guide in root cause analysis with knowledge of 5 Whys, Ishikawa/Fishbone, A3 Analysis.
• Implement and review effectiveness of Non-Conformance Reporting and CAPA.
• Accountability and ownership of Quality Metrics and responsible for maintaining Team Leading Quality indicators and actioning corrections on indicators of lagging Quality.
• Review active corrective and preventive actions are adequate.

Regulatory, Standards and Compliance

• Analyse/review current product and processes are complying to ISO 13485, QSR, EN, etc., champion compliance to global regulations such as FDA, MDR, support internal and external audits.
• Review corrective actions to periodic line audits in relation to compliance, to production controls and review audit findings for Non-Conformance and CAPA.

Product Quality, Control and Disposition

• Support activities in material review board, material identification, segregation, and defect classification.
• For non-conformance critical issues, support on immediate corrective actions and guide investigation, root cause analysis and bounding of non-conformance as per established process.
• Review and approve non-conformance reports for compliance and completeness.

Product and Process

• Review and approve failure modes cause analysis for products and processes – PFMCA; review, analyse and approve impacts of proposed change to a process for enhanced risk levels that go beyond the capability of current controls, or if a proposed change will result in potential non-compliance to a required standard.
• Assess risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Review, analyse and approve proposed changes to risk management documentation.
• Resolve effectiveness of these techniques on previously implemented improvements.
• Analyse and review implemented process monitoring and control methods for appropriateness and consistency with the level of process/product risk.
• Analyse, review and approve standard and non-standard sampling plans.

Risk Management

• Conduct failure modes cause analysis for products and processes.
• Document, rationalise, 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.
• Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.
• Resolve effectiveness of these techniques on previously implemented improvements.

Qualification and Validation

• Reviews and approves IQ, OQ/PQ and CSV for manufacturing and test equipment
• Ensures the implementation of suitable measurement systems through the principles of MSA and analyse, review and approve that collected data is unbiased, reliable, and consistent e.g., Gauge Repeatability and Reproducibility
• Provides guidance on the analysis of sources of variation in measurement systems, with a view to control of variation.
• Ensures effective quality strategies are carried out for the validation of test methods, process and design.
• Support New Product Introduction (NPI) as part of design transfer and establishing process stability for NPI through the review, analysis and approval of implemented statistical process control activity and monitoring of process performance.
• Approval of change control of NPI changes for compliance to established standards, regulations and procedures.
• Support Product/Process Transfers and establishing process stability for transfers through the review, analysis and approval of implemented statistical process control activity and monitoring of process performance.