Quality Assurance Scientist
12 month FTC
Up to £40k per annum
Scope of role:
To provide a robust, practical and efficient quality assurance service to a team of scientists within the IVD/medical device space.
Reporting to the Quality Manager, your core duties will focus around handling the reporting process for non-conformance and CAPA's, document control and first drafts, some risk management and change control.
In addition, you will be working to stringent ISO 13485 regulations in relation to preparing for audits, the protocols for medical device development and production (and communicating them to the wider team) and updating, maintaining and managing the global e-QMS.
You will be supporting the team with validation activities of the IVD's, managing the design control for experiments, and participating in regular Quality review meetings with analysis of KPI metrics and delivery any remedial training required.
BSc or equivalent in a Science, Clinical or Engineering-related discipline OR at least 3 years of hands-on industry experience in medical device or pharma related setting
Strong knowledge of ISO 13485 and US FDA 21 CFR Part 820. Knowledge of medical device regulation would be desirable
Demonstrable experience in handling NCR and CAPA procedures and implementing remedial actions
Excellent problem solving skills, ability to work cohesively in small and busy teams, exemplary communication skills, sound influencing skills
If this sounds like the challenge you are seeking, please contact Bec Johnston: / (phone number removed)
Document Management Systems
Corrective And Preventive Action (Capa)
Title 21 Of The Code Of Federal Regulations