Gambro is looking for Quality Director

QUALITY DIRECTOR,SWEDEN Gambro seeks a new Quality Director for its operations in Lund, Sweden.As Quality Director, you will have a crucial role in the management team with the main responsibility of ensuring that all quality aspects of the business are optimised to focus and sustain commitment to quality manufacturing and logistics in order to achieve customer needs and expectations.In this highly diverse role you will also have the opportunity to step outside of your function of expertise and work both hands-on and strategically on the development of quality operations as well as develop effective interactions with the leaders and key stakeholders in all other functions of the Gambro site in Lund.This position will report to the VP of Quality Operations.Competence Requirements - Extensive experience in QA management within medical devices, experience of quality systems activities, controls needed for MD production and changes, improving processes, validations and risk management is merited.- Direct working experience and knowledge with FDA inspectors and other external auditors or regulations for compliance also required.- An understanding of manufacturing processes including; systems used in production as well as distribution centers. - An understanding of tools such as 6-Sigma, lean principles and other tools used in manufacturing.- Thorough understanding of CAPA, document control system(s) and complaint handling systems.- Work experience in the development of procedures/policies for production, logistics and supplier management including products that are compliant to regulations/standards.- The ability to negotiate with other leaders to improve quality of products; supplier selection process; who is able to support the application of tools like 6 Sigma, lean principles, Lean Sigma etc; as well as the ability to assess situations and determine level of involvement and best style to use to obtain effective solutions.- Excellent communication skills as well as determination to build consensus in the most challenging settings in order to address facilities issues, transition of new products into manufacturing, product changes, supplier changes, complaint investigations, logistics issues or continuous improvement challenges, and organizational issues - The proven ability to win the respect of colleagues independent of their reporting status, while simultaneously being a motivating leader with a positive approach that can be infectious for the organisation.- A strong charismatic personality, whom can break down barriers but most importantly work towards creating strong team cohesiveness.- An international business approach, having had experience working abroad and with different cultures.- Fluent in both oral and written English, knowledge of the Swedish language is also merited. Apply to the position via www.academicsearch.se or by clicking on the link below http://www.appsgate.com/asi/kgam30.nsf/web.nysokande