To provide expert Quality support to Operations on Night Shift, in ensuring operational goals and objectives are achieved for the plant. Responsibilities - Assists engineering in providing manufacturing support by reviewing and analyzing data to determine manufacturing issues and trends. May also train operators on processes and engineering changes and perform operator certification on-the-job training and testing.
- Problem solving and continuous improvement investigations. Troubleshoot product and process related issues and identifies root cause.
- MRB: Reviews and dispositions non-conforming material by utilizing quality tools and by developing knowledge of manufacturing practices and procedures.
- Conducts audits of manufacturing and related areas to assess compliance with internal procedures; reviews finding to determine compliance risk and systems issues. Ensures PB’s on the line are Audit ready by conducting internal audits.
- Learns traceability and inspection requirements, learns statistical process control criteria, learns how to develop manufacturing instructions, and create training sheets and certifications.
- Drive Defect awareness training with product builders with the assistance of the Core Team.
- Trending and Analysis of key Quality Metrics.
- Problem solving and continuous improvement investigations. Troubleshoot product and process related issues and identifies root cause.
- Responsible for the final Process Monitor Release for products prior to distribution.
- Completes MRB Dispositioning and manages MRB Statics.
- eRelease: Confirms accuracy of sterile load prior to shipment.
- Records manufacturing release requirement results. Reconciles samples that have been recorded in the eRelease system. Initiates exceptions for failing manufacturing release requirement results.
- Qualifications: NFQ Level 6 or above in Science or Engineering Discipline.
Experience: - Minimum of 2 years’ experience working in a medical device industry preferably experience with dispositioning rework product and a good knowledge of MES/MES Business Objects Reporting.
- Decision making ability coupled with the ability to work on one’s own initiative and with minimum supervision is required.
- Good interpersonal, planning & prioritising and communication skills are required for this role.
- Reminder: Please get approval from your supervisor/manager before submitting your application
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