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Quality Engineer

  • Division: Engineering
  • Contact Email: ranait.coughlan@collinsmcnicholas.ie
  • Job Ref: 23972

Fantastic new opportunity for a Quality Engineer to work as part of a well-established medical device manufacturing company in the Midlands, this is a full time,12 month contract position. As the Quality Engineer, you will work as part of the Quality Team reporting to Quality Manager. You will be responsible for supporting quality engineering activities with regards to the Quality Management System, product robustness changes and compliance related projects, ensuring technical correctness, and compliance with requirements of global regulations.

Responsibilities Include:

  • Co-ordinate the provision of QA resources to support Materials inspection and Operations
  • Provide Operational QA Support for products and process
  • Conduct detailed root cause analysis and define corrective and preventive actions for NCR
  • Take part in continuous improvement activities to streamline the process
  • Work with engineering teams to identify trends in failures, support root cause analysis and implementation of corrective actions
  • Conduct Internal audits and Lead KATA investigations towards root cause
  • Develop Inspection plans for Incoming inspections, in process and Final QA inspection for products manufactured
  • Detailed Review and approval of Risk Managements files
  • Review and Approval of Change Orders associated with components and manufacturing process

Key Requirements:

  • Bach Degree in Engineering/Science discipline with a minimum of 4 years working within a regulated industry
  • Excellent working knowledge of ISO 13485 and 21CFR820 and MDSAP program, along with exposure to other regulations. Working familiarity with IEC 60601 a distinct advantage
  • Experience in working within a CAPA program, and other quality management systems and experience with leading and participating in several projects concurrently
  • Experience in internal auditing to QSRs and ISO 13485 requirements
  • Strong Problem-solving skills & Attention to detail and accuracy – essential
  • Ability to work well under deadlines and pressure

For a confidential discussion about this opportunity, please contact Ranait Coughlan

ranait.coughlan@collinsmcnicholas.ie

(090) 6450664 (01) 66 200 88