Our client, a leading Medical Device organisation, are looking to recruit a Senior QE for their site in Cork on a permanent basis.
- Manage, mentor and coach a high performing team of Quality Engineers & Technicians working on project based activities.
- Provide effective and responsive Quality support to project teams to meet their objectives of safety, quality & compliance, timeliness & cost.
- Communication and escalation of key Quality concerns/issues
- Work cross functionally to ensure all process variables and their interactions are adequately defined, failure modes in process have been identified and appropriately addressed
- Drive and implement process improvements to ensure predictable processes across all product lines (e.g. Risk Identification & Reduction, Yield improvements, Customer complaint reduction, Error proofing, Cost Reduction initiatives, Process Automation activities).
- Ensure Regulatory compliance in area of responsibility to all medical device regulatory agencies (e.g. FDA, DEKRA, and BSI).
- Identification and implementation of appropriate statistical techniques to monitor process performance (e.g. In Process monitoring, SPC, CpK analysis, sampling techniques).
- Approval of change requests for product, process and quality system changes.
- Customer complaints: Partner with Design Assurance to ensure appropriate focus on customer complaint analysis and trending through product commercialisation ? taking action where required.
- Problem Solving: Lead a diverse scope and complexity of problem solving activity where analysis of data requires evaluation of identifiable factors. Exercise authority and judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Demonstrate a broad knowledge of a variety of alternatives and their impact on the business unit.
- Validation: Align with Process Development and Manufacturing Engineering to identify and define appropriate process and product validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval.
- Support compilation of required Regulatory documentation (e.g. Technical files, Design Dossiers, Product transfer files, Essential requirements).
Experience & Qualifications
- Requires a minimum level 8 relevant Engineering / Science degree
- Minimum of 4+ years? experience within the medical device or pharmaceutical manufacturing industry - people management experience an advantage.
- Strong knowledge of quality principles and the ability to utilize these methods in a manufacturing environment.
For further information on this Senior Quality Engineer please contact Nicola O?Connell on 091730022 / firstname.lastname@example.org
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