|Job Ref:||204644502||Employer:||cv-library.co.uk||Industry:||Civil and Structural||Job Type:||Permanent||Country:||United Kingdom||County/State:||Cambridgeshire||City:||Cambridgeshire||Address:||Post Code:||CB1||Post Date:||08/10/2016 02:22|
A Fantastic opportunity has arisen for a Validation Engineer (Medical Devices) to join a growing, innovative company. The successful candidate will be involved in the development of medical and medicinal products especially in the product realisation and design transfer activities and it would be a significant advantage if you were experienced in developing the necessary regulatory documentation including risk management, design inputs, outputs, design verification and validation, DMR, etc.
Based in the Home Counties area, our client is an expanding product design specialist. Market leaders in their field this company offers an excellent range of benefits and the opportunity to develop skills and gain exposure to aid career development.
• A 1st class or 2:1 degree in Engineering (or other physical science)
• Previous experience of validation within the medical device/ pharmaceutical industry
• Excellent knowledge and working experience of ISO 13485 medical device standard
• Experience of medical process validation DQ, IQ, OQ, PQ and methods such as DOE
• Experience in ISO 14971 - Application of Risk
• Management to Medical Devices
• Risk Management Files; Plans, Hazard Assessments, Design FMEA, Process FMEA
• Experience with injection moulding, tooling and machinery
• Working to ISO 13485, ISO15378 and 21CFR820 quality requirements
Apply now to be considered for this excellent job opportunity!
Medical Device, Validation, Process Validation, ISO13485, FDA, IQ,PQ,OQ, DOE, CFR,
Harris Lord is acting as a Recruitment Agency in respect of this vacancy