Technical & Engineering JobsQuality Engineer II

  • CJ50433
  • Permanent
  • Cork, Cork City

Collins McNicholas

Quality Engineer II – Cork

Role Responsibilities:
• Supervision of Quality Technicians and QC Inspectors.
• Drive and implement process improvements to ensure predictable processes across all product lines (e.g. Risk Reduction, Yield improvements, Customer complaint reduction, Error proofing, Cost Reduction initiatives, Process Automation activities).
• Provide effective and responsive QA support to Operations to meet their areas objectives of quality, cost and output.
• Ensure all process variables and their interactions are adequately defined. Ensure all failure modes in process have been identified and addressed. (e.g. Use of DOE studies, FMEAs).
• Drive and implement plant wide quality system improvements.
• Ensure Regulatory compliance in area of responsibility to cGMPs of all medical device regulatory agencies (e.g. FDA and TUV).
• Provide functional expertise to other support functions on quality related issues (e.g. regulatory requirements, statistical techniques, sampling principles).
• Identification and implementation of appropriate statistical techniques to monitor process performance (e.g. SPC, CpK analysis, sampling techniques).
• Identification and implementation of appropriate statistical techniques to monitor process performance (e.g. SPC, CpK analysis, sampling techniques).
• Approval of change requests for product, process and quality system changes.
• Customer complaints: Analysis of returns, approval of analysis reports and analysis of complaint trends.
• Validation: Define process and product validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval.
• Compilation of required Regulatory documentation (e.g.Technical files, Design Dossiers, Product transfer files, Essential requirements).
• MRB: Review of MRB trends and identification of appropriate corrective actions when required.
• Perform internal quality audits.
• Support the implementation of Lean Manufacturing across the site.
• Transfer and implement product and processes from development or from another manufacturing facility.
Role Requirements:
• Working knowledge and application of business and technical concepts, procedures and practices.
• General knowledge of industry practices, techniques, and standards.
• General understanding of business unit/group function.
• Exercises judgment when interpreting company policies and procedures to resolve a variety of issues.

For a confidential discussion and more information on the role, please contact Lauren McCarthy.

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