JOB DESCRIPTION SUMMARY

We are recruiting a Quality Technician who will be working closely with Manufacturing and Quality Engineering to ensure Quality Systems are maintained in compliance and adhered to by all personnel.
These systems include but are not limited to Quality Notifications, Procedures, performing inspection and various tests, temporary deviations, supporting internal and third party audits, training (C2C), customer complaints, Change Control, Validation, CAPA, etc.

• Perform routine verification of the manufacturing areas to assure they are operating per their procedures and validated parameters, all documentation is complete and accurate, and the areas are compliant to regulations and GMP.
• Raising Quality Notifications in accordance with standardized practices and ensuring that the non-conforming product is segregated and identified in accordance with the relevant procedures. This includes the investigation into the root cause of the non-conformance.
• Perform inspections and tests as per the applicable SOPs, protocols, and sampling.
• Device History Record (DHR) auditing to ensure that all records are complete and comply with GMP requirements.
• Actively participate in continuous improvement teams and activities, including 5S, blitzes, shift start-up, updating.
• Product inspections as required by the process control plans which may include moulding product dimensional checks, needle functional checks and any others that require Quality support.
• Support SAP/Flexnet requests - blocking and unblocking of product, investigating product quantity discrepancies
• Support of Validation / Trial runs in manufacturing ensuring product is controlled appropriately.
• Provide support for internal audits, third party regulatory audits and customer complaints as required.
• Supporting the Quality Engineering team on reasonable requests as they may arise.
• Supporting / coordinating product returns as they may they arise