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Quality Engineer

  • Sector: Engineering
  • Contact Email: gillian.nicholson@collinsmcnicholas.ie
  • Job Ref: 18360

The Role:

A 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 permanent position available for an immediate start.

 Responsibilities:

  • Co-ordinate the provision of QA resources to support Materials inspection and Operations.
  • Provide the team direction to support team development through training
  • 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.
  • 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,
  • Lead KATA investigations towards root cause

Qualifications:

  • The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
  • Engineer/Science qualification (Minimum BSc or BEng) with minimum of 2 years working within QA in a multi-national medical devices manufacturing environment.
  • 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 dealing with external Regulatory bodies to manage certification and audit program including following up actions of the Quality Management System
  • Experience in working within a CAPA program, and other quality management systems and experience with leading and participating in several projects concurrently.
  • Ability to accurately scope projects and consider the full impact of decisions and actions taken.
  • Attention to detail and accuracy – essential.
  • Ability to work well under deadlines and pressure.
  • Strong Problem solving skills for developing creative solutions and meeting objectives are required.
  • Experience in internal auditing to QSRs and ISO 13485 requirements.
  • Experience in Six Sigma / lean techniques and statistical analysis a distinct advantage

For further information on this opportunity please contact Gillian Nicholson at gillian.nicholson@collinsmcnicholas.ie

Or call Gillian on 90 6450665