Quality Assurance Manager
Witham, England, United Kingdom
DD
be responsible for ensuring that the systems and processes in place for current Good Distribution Practice, MHRA guidelines, Home Office controlled drugs license and ISO-9001: 2015 and ISO 13485 standards are adhered to and that the procedures and appropriate training for the team and wider DD … Distribution Authorisation, GDP Guidelines 2013/C 343/01, Human Medicines Regulations 2021 relevant MHRA Guidelines, legal requirements, and updates Ensure compliance with ISO 9001: 2015 and ISO 13485: 2016 standards. Ensure the QMS is implemented and maintained. The RP must approve, sign and date, all … environment Minimum 2yrs experience in a quality managers/Management position Detailed knowledge and understanding of Medical Device legislation Good knowledge and understanding of ISO13485:2016 and associated standards Good working knowledge of product classification for medical devices, specifically selecting appropriate classification, and conformity assessment route. Formal Training in ISO13485 more »
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