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Brightpath Recruitment Ltd.
Office 4, Sligo Airport Business Park,
Strandhill, Co. Sligo.
Tel: 071 9128266

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Quality Assurance Engineer

Location: Roscommon
Entered: 14 Dec 2018
Duration: Permanent

Quality Assurance Engineer

Our client who is a leader in the international contract medicaldevice market is seeking a Quality Assurance Engineer for a permanentrole in Co Roscommon.

What’s onOffer

This is a permanent position with excellent career developmentopportunities. Our client has sites in Ireland as well as internationally andprovides integrated technical solutions and full manufacturing services forcompanies of all sizes. 

Our client’s focus is to provide world class medical products and services. Reporting to the Quality Assurance Manager, the Quality Engineer willprovide ongoing support to the manufacturing team in an effort to maximiseproduction quality performance, including identifying root cause, implementingcorrective/preventive action on all quality issues in production. The scope ofrole will also include addressing any customer related issues identified in themanufacturing process and validation of new processes and products.

What you will be doing:

  •  Review, update andmaintain existing quality management processes and procedures
  • Ensure qualitystandards are adhered to, and all production processes are carried outaccording to procedures
  • Raise qualityprofile and operating standards within the business
  • Initiate and drive ContinuousImprovement programs
  • Ensure that theCompany retains ISO accreditation
  • Conduct internalaudits
  • Host audits of theCompany’s operations by external bodies (for example audits from customers, auditsrelating to certification to official standard ISO 9001, ISO 13458)
  • Maintain detailedand accurate quality records, data analysis and documentation,
  • Non-conformingMaterial, Customer Complaints, CAPA investigation, analysis and improvement,
  • Data Analysis andTrending, Statistical Process control, Root Cause Analysis and theImplementation of Corrective Actions
  • Ensure qualityinspection instruments are accurate and regularly calibrated, tested andaudited,
  • Prepare and execute Process/ProductValidations,
  • Ensure new productintroductions and change controls are effectively managed in accordance withthe ISO requirements when appropriate,
  • Support the introduction of new product linesthrough development of Product Inspection Plans, Process FMEAs and RiskManagement Plans.

What you need to be successful:

  • Degree in Quality Assurance or related
  • Minimum 5 years experience in a similar Quality Engineer role preferably in the Healthcare/Medical Device sector



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