senior quality engineer temp 9 months ref our leicestershire based client offers a comprehensive range of medical and hygiene consumables primarily for use in infection control wound care and operating theatre environments they are one of the leading suppliers of healthcare disposable products to the national health service through their brands they focus on providing a range of products and services that enable customers to manage their medical consumables supplies in an efficient and cost effective manner they are currently recruiting for a senior quality engineer to join their team for a period of 9 months responsibilities ensures that all products sourced from third party suppliers products comply with internal and regulatory standards ensure qms complies with european directives mddppe and iso13485iso9001 implement qms isomddppe improvements ensure all changes to products are captured in ce technical files host regulatory body and customer audits where applicable ensure products comply with regulatory affairs updates process all customersupplier complaints in accordance with sop perform and report internal and supplier audits to agreed schedule ensuring corrective actions are completed to schedule deputise for technical qa manager give technical advice and training where appropriate achievement and maintenance of relevant quality standards analyse quality kpi s and implement capa s where appropriate ensure all complaints timelines are meet as described in sop build and maintain library of tech data sheets and specification and update as necessary ensure supplier approval process documentation is complete without deviation develops and maintains product specification and technical data sheet library issuing of product certification to customer ensuring supplier release documentation is complete actively participates in all internal and external auditing activity all pre qualification of suppliers skills experience hnchndbsc level in an appropriate science or quality discipline desirable extensive quality experience in med devpharma regulatory affairs experience desirable maintain and develop device technical files develops and maintains an understanding of medical device standards regulations and directives ie bs en iso 134852003 medical devices ce marking directive eec personal protective equipment directive eec medical devices qsr auditing experience ideally registered assessor it literate quality management systems development and improvement excellent verbal communication skills and technical writing ability excellent interpersonal skills to interface with all levels of company structure as well as representatives of outside agencies or companies decision making and problem solving skills flexible and resilient able to deal with time constraints and adversity required leadership behaviours self motivated decision making drive high performance focus on customer communicate effectively strategy and planning negotiating skills to influence others role temp 69 months location leicestershire salary k pro rata