Quality Systems Officer

Proclinical Limited
25 Sep 2017
03 Nov 2017
Contract Type
Full Time
A renowned life sciences company has an opportunity for a Quality Systems professional to join their team in Cambridgeshire, UK. Job Role: As the successful applicant, you will be responsible for effectively leading change management processes, establishing and maintaining Design History Files, supporting deviations and non-conformances in co-ordination with key third party organisations. Job Responsibilities: - Responsible for change management processes, ensuring that all raised change requests are logged and assessed in an appropriate manner and following up on the required actions. - Supporting the assessment of change requests and modifications to device design documents or production and assembly processes. - Ensure procedures and processes are followed to maintain the relevant Design History File and associated documentation with respect to change management activities. - Ensure appropriate quality processes and records are set-up and maintained to ensure compliance with company procedures, GMPs and required Device guidelines. - Responsible for the management of identified deviations and non-conformances and ensuring that CAPAs are implemented. - Supporting trend analysis and risk assessment processes which ensure long term supply remains compliant with specifications and Design History File requirements throughout the life-cycle of the products. Job Requirements: - Experience working within Medical Devices and strong understanding of ISO 13485 requirements. - Application of ISO 14971 To Apply:Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.In case you have difficulty in applying or if you have any questions, please call Alex Tooulas on **************** or upload your CV on our website - *******************. A full job description is available on request.ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
This job was originally posted as www.jobsite.co.uk/job/959117539