Quality Inspector with 3+yrs Medical Device assembly experience required by growing medical devices company in Sligo

Requirements:

  • Leaving Cert plus minimum 3-year Medical Device assembly experience
  • Understand general principles of EN ISO 13485 & FDA 21 CFR 820
  • Competent in Inspection method and reading drawings and specifications
  • Proficient computer skills
  • Decision making ability coupled with the ability to work on one’s own initiative and with minimum supervision is required, and ability to multitask and prioritise
  • Good interpersonal skills and organisational skills
  • Excellent attention to detail
  • Documentation skills
  • Competent in inspection methods and reading drawing and specifications
  • Understand the principles of product/parts and FIFO
  • Communicates any concerns about work process regarding environment impact, health or safety issues to their manager
  • Forklift Licence would be an advantage

Responsibilities:

  • Approves incoming materials by confirming specifications; conducting visual and measurement tests; rejecting and returning unacceptable materials
  • Routine Final QA Product Inspections of finished parts in production by confirming specifications; conducting visual and measurement tests; communicating any non-conformances to Production Manager & Quality Dept
  • Routine Environmental Monitoring; pressure differential readings, Particulate Monitoring, Microbial Monitoring
  • Document inspection results by completing reports and logs; inputting data into quality database
  • Problem solving and continuous improvement investigations
  • Perform internal audits as required
  • Review and update QA Documentation
  • Provide assistance and support to the Quality Engineering and Operations function
  • Drive continuous improvement and best practices in QMS “Right First Time”
  • Maintains safe and healthy work environment by following standards and procedures; complying with legal regulations
  • Updates job knowledge by participating in educational opportunities
  • Ensure compliance to all applicable regulatory standards and cGMP procedures and practices
  • Review documentation for completeness
  • Responsible for scanning, filing, backing up and archiving quality documentation to maintain the quality management system
  • Maintain and control all external supplied documentation which may affect product realisation

emer@emtechrecruitment.ie 

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