1. The QA specialists make sure the medical equipments manufactured, adhere to the best manufacturing practices and the ISO 13485:2003 Quality Management system criteria is met.

(a) The Quality assurance specialists has to perform and maintain QA procedures all times to ensure the facility operates and complies according to the ISO 13485:2003 Quality system regulations. The QA specialists also need to keep themselves up to date with all the QSR requirements in coordination with the Regulatory affairs and be ready to implement any changes accordingly .

(b) The challenges in this position include conducting timely audits in all the departments to ensure the production workflow meets the actual quality standards. All the procedures and processes should be reviewed periodically and any changes identified must be properly documented and recorded. The real challenge here is the multi platform communication, coordination and the time that takes to review and complete these audits. These audits has to be conducted across various departments within the facilities including Purchasing, Finance, Warehouse, …show more content…
This is to ensure the production workflow keeps up with the production timeline. The effective way to counter this problem is to maintain an uninterrupted production line even on the short staffed days by introducing over time and other perks for the production members. The other challenges in this position include communicating with the vendors, suppliers or distributors for any delays caused in the production. This includes the shortage of raw materials or the change of parts or materials ordered, any costs associated that need to be reprocessed through the Finance and Purchasing department. Any internal or external delays including any miscommunication caused need to be addressed to the Top management and need to be resolved without causing a huge impact in the production