Quality Assurance Specialist

2 weeks ago

Fermoy, Cork, Ireland beBeeQuality Full time

**Job Title:** Quality Technician

As a Quality Technician, you will play a critical role in ensuring customer satisfaction by monitoring and controlling all related customer processes. You will be the customer interface for quality metrics and improvement initiatives.

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**Key Responsibilities:**

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  • Support quality process definition, set up, verification, and improvements.">">
  • Complete in-process testing on Product.">">
  • Complete weekly leak & burst testing on product to ensure product is sealed correctly as per the required specification.">">
  • Verification of Critical Process Parameters (CPP's) & Line Clearance activities.">">
  • Conduct internal process audits to ensure conformance and effectiveness of the Quality System.">">
  • Supporting Audits by demonstrating product testing requirements & best practices.">">
  • Feedback and improvement on Customer 'Supplier Quality Issues'.">">
  • Prepare for and attend daily engagement process meetings.">">
  • Identify improvements through Quality review and meetings on Quality, Yield, flow, documentation, control etc.">">
  • Escalation of Quality Issues where necessary & conduct non-conformance investigations when required.">">
  • Perform weekly environmental monitoring sampling of the ISO Class 8 Cleanrooms.">">
  • Prepare and review sterile release packs (Endotoxin & Bioburden test reports).">">
  • Conducting & verifying releasing of sterile product.">">
  • Supporting SMT line first off verifications along with verifying line clearance activities.">">
  • Reviewing & approving unplanned maintenance activities when required across multiple assembly lines.">">
  • Determine Lot suitability for release by reviewing production logs and final batch records against product specifications, procedures and electronic data systems.">">
  • Review and approval of Design History Records (DHR) by obtaining and verifying the contents of DHR's against the relevant documentation requirements.">">
  • Interacting with manufacturing execution system (MES) & Oracle Agile systems daily to ensure products are assembled as per the required specification.">">
  • Work space compliance to Site requirements, ESD, MSD, Housekeeping (5S), Safety etc.">
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