Quality Systems Compliance Auditor, Medical Devices, Bern

Responsibilities You will be responsible within Europe for Quality Systems Compliance activities applicable to European Union and country specific regulations and standards (e.g. ISO, SFDA) and as appropriate to best business practices (e.g. AAMI, ISO). This includes auditing, monitoring, advising and consulting on quality systems associated with the Companies locations and as part of Due Diligence activities. In conjunction with the Companies European counterparts you are in charge of maintaining and monitoring compliance to company policies for quality systems compliance. You will be assisting in the identification and establishment of the necessary procedures, tools and methodologies to cover all quality systems activities. In your role you advise and consult within the Company and with suppliers to facilitate timely and complete resolution to quality and computer systems compliance issues as well as consult on departmental or company-wide projects for quality systems compliance including, but not limited to preproduction, production and post-production activities. Moreover, you will be responsible for partnering with PD and Operations to ensure alignment and consistent application of quality systems procedures and methodology. Your Profile For this position I am searching an autonomous working individual. You have a university or college degree with at least five years experience in a similar role with direct experience working in supervising quality and/or computer systems compliance activities in a medical device or pharmaceutical company. Experience in managing and in performing audits in an FDA or similarly regulated environment or in a notified body environment associated with medical devices or pharmaceuticals will be considered an important asset. We are in search of a pragmatic and analytical worker with excellent organizational and communicational skills. Excellent soft skills when working with internal staff members, external consultants and with suppliers are essential. Fluent oral and written skills in German and English as well as the willingness to travel are required. My customer offers you a professional, international, dynamical and high quality working environment, where personal development is stimulated and personal initiatives are encouraged. Your Development Plan will challenge you to further develop your personal skills and competencies, to build your career within the global organization. I am Jennifer Herter, a recruitment specialist in quality assurance recruitment for medical devices. I am currently working with many organisations in Switzerland. This means that I can offer you multiple vacancies for your job search. After application, I will contact you for a confidential discussion, when we will agree processes and next steps. For more information on this job, or others like it, please contact Jennifer Herter at Real Pharma on 0041 (0)43 50 80 972 or j.herter(at)realstaffing.com

(Real Staffing Group acts as an Employment Agency and an Employment Business)