Shift QC Lead
BD
Dublin, Leinster
6d ago

Job Description Summary

Shift QC Lead

BD, also known as Becton Dickinson, provides pen needles for the care of Diabetes patients globally. The plant, based in Dun Laoghaire, runs 24 / 7 and is the Worldwide Centre of Excellence for Pen Needle Manufacturing within the BD organisation, producing 4.

6 billion medical devices annually. Looking to join our team of 450 people across Operations, Engineering, Quality and R&D in Dun Laoghaire.

Reporting to the Senior Quality Engineer, Shift QC Lead duties will include active participation in non-conformance investigations and lot disposition decisions, raising of Quality notifications in response to quality non-conformances and ensuring corrections are completed and confirmed on assembly processes.

The Shift QC lead will provide QA support to the shift manager when required.

Responsibilities :

  • Monitoring the activities of the Quality Control Lab to ensure optimal efficiency and compliance with all regulatory requirements in the QC lab environment.
  • Preparation of relevant work sheets and execution of In Process inspection tests.
  • Ensure required quality testing is carried out; carry out inspections to meet the standard set by the organization Participate in the Change Control Process.
  • Review In process controls, SOP’s, Test Methods, and specifications to ensure Lab inspections are being carried out as per design intent.
  • Analysis of data, quality metrics and trends of in-process inspection data.
  • Liaise with relevant personnel regarding flow of product through QC department and other issues that arise.
  • Preparation, review and approval of technical documentation and perform training as required in the area.
  • For this role we are looking for candidate with 3+ years of experience in a similar position qualified to a minimum of NFQ Level 6, preferably a Science degree incorporating Quality Assurance.

    You will have a good knowledge of ISO standards and FDA and would have experience using SAP and Trackwise.

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