|Job Ref:||204555193||Employer:||cv-library.co.uk||Industry:||Civil and Structural||Job Type:||Permanent||Country:||United Kingdom||County/State:||Yorkshire||City:||Leeds||Address:||Post Code:||LS7||Salary:||£27000 - £29000/annum||Post Date:||10/10/2016 09:16|
Calibrate Engineering Recruitment (part of the Brewster Pratap Group) are working with a Leeds based client who are recruiting a Quality Engineer/Microbiologist.
Responsible for maintaining environmental monitoring, Sterility Assurance Levels, supporting manufacturing, participating in internal/external audit programmes and Non-Conformance Investigations to support the development and improvement of the SI Quality Management System in accordance with specified business specifications and standards.
* Develop and maintain Environmental Monitoring procedures in accordance with BS EN ISO 14665 and provide relevant operator training.
* Establish and maintain relevant sterilisation QMS documentation for device sterilisation methods to meet requirements of BS EN ISO 11137.
* Responsible for control of Sterility Assurance Levels of all products, including dose audits and ensuring appropriate bioburden testing is carried out.
* Support manufacturing to ensure compliance with 21 CFR part 820 and BS EN ISO 13485:2012
* Conduct 1st and 2nd Part Audits in accordance with audit schedule.
* Assess internal and supplier non-conformances, deviations and out of specification results to ensure all relevant data is available and the nature of the non-conformance is fully understood. Create a record through the CAPA system, identifying immediate actions and complete failure investigation/root cause analysis.
* Establish corrective/preventive action plans where necessary and verify/validate effectiveness of actions.
* Ensure compliance with appropriate quality system procedures in order to maintain comprehensive and accurate records.
* Ensure Technical Files are effectively maintained and comply with MDD 93/42/EEC as amended by 2007/47/EC, including but not limited to maintenance of Essential Requirements, Risk Management and Post Market Surveillance.
* Support other functions within the business to ensure compliance with relevant standards and regulations.
Thorough knowledge of regulatory authorities
Biological Science/Engineering degree (or qualified by experience)
2 years' experience in medical devices or Pharmaceuticals Industry.
Trained Auditor (Desirable).
Competitive basic salary
On-going Training & Development
Calibrate Engineering Recruitment is a division of the Brewster Pratap Recruitment Group focusing on the recruitment of talent in engineering, technical and operations jobs in South Yorkshire, West Yorkshire, East Yorkshire, North Yorkshire, Lincolnshire and Nottinghamshire. If you are interested in discussing this job in more detail or any other aspect of accountancy and finance recruitment we would really like to hear from you. Please visit our website at (url removed) for more information on engineering Jobs, engineering recruitment, manufacturing Jobs or manufacturing Recruitment