Overview
The primary function of this role is the inspection of raw materials (IQC), finished devices (FQC), packaged devices (PKQC) , sterilised devices (PSQC) and device history records (Batch Release) ensuring that inspection procedures are followed at all times and that all product and paperwork passes specified quality control requirements before shipping to customers.
Reporting to: Supervisor, Quality Control
Find out more about Cook Medical here
Responsibilities
- Ensure that all products which are manufactured at Cook Medical are inspected as per the relevant FQC instructions and that it meets the required quality control specifications before it is shipped to customers.
- Ensure that all raw materials received on site at Cook Medical are inspected as per the relevant IQC instructions and that they meet the required quality control specifications before release for use in manufacturing.
- Ensure that finished goods packaged at Cook Medical are inspected as per the relevant packaging quality control instructions and that they meet the required quality control specifications.
- Ensure that product which has completed the sterilisation cycle is inspected as per the relevant instructions and that its meets the quality control specifications before it is shipped to customers.
- Ensure that all device history records are reviewed in line with Batch Release procedures and are compliant before product is released to stock.
- Ensure compliance with GMP practices i.e. gowning correctly, adhering to CMA rules, adhering to relevant line clearance procedures, following procedures and completion of paperwork accurately.
- Highlight any potential issues to Team Leaders.
- Contribute to attainment of overall KPI targets for the QC group by achieving daily/weekly quality and output targets.
- Working as part of a QC team within the Controlled Manufacturing Areas.
- Ensure that Cook’s Code of conduct is considered in all business matters carried out on Cook’s behalf.
Qualifications
- Previous experience in medical devices, while not essential is advantageous.
- Good communication and inter-personal skills.
- Ability to work as part of a team.
- Some flexibility as regards working hours/days.
- Willingness and availability to travel on company business.
