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Quality Assurance Manager Smorum Denmark,  

Posted on : 16 April 2017

Project Description

Would you like to work with products that actually change the lives of people worldwide and do it in a fast-growing company? Then you may be a good match for Oticon Medical. Right now, we are looking for a dedicated and highly skilled QA manger to support our fast-growing business.Job DescribtionYou ensure implementation and maintenance of the Quality Management System   The position is situated in our Gothenburg office working with bone anchored hearing solutions. In your new job, you will be responsible for maintaining the quality management system and supporting the organisation in quality compliance. This includes but is not limited to:  Preparing, implementing and supervising the compliance of quality procedures Co-hosting external audits Drive quality system projects incl alignment with sister companies and implementation of new standards and regulations influencing QMS (like ISO 13485, MDSAP, MDR) Perform QMS trainings of the organisation Perform internal audits and audits of subcontractors and distributors Complaints and CAPA handling  As this is a new position created to support a growing organisation you will have the opportunity to influence the role depending on your skills. We offer you the opportunity to join an enthusiastic team focused on the continued growth and expansion of our company. You can look forward to joining the QA/RA team consisting of 3 dedicated and highly skilled colleagues. The team is responsible for the quality management system and all regulatory aspects related to our products. Besides your closest colleagues you will also be working closely together with other functions in different projects. You will be reporting to the Senior Director QA/RA & Operations Competence We are looking for someone with a passion for efficiency, structure and compliance and understand the challenges of working in a fast-growing environmentYou should have worked at least 3 years with quality and regulatory in a medical device company, preferably class III products. Basically, you have thorough understanding of AIMDD, MDD, ISO 13485 and QSRYou are an outgoing and positive team player who can work structured and independently coordinating your own work but also by working as a team in a cross functional project with your colleagues.Your professional style is characterized by your ability to work structured and focused in a technical and professional manner - no matter the deadlines or the pressure you experience.  Besides that, we expect that you re pragmatic and strive for efficiency in all that you do Think and act holistically and like to take responsibility Skilled in creating and maintaining good relations to all parts of the organization  Know how to benefit from multi-site and multi-cultural development teams Want to join the team?Then send your application today, as we are currently screening applications, but no later than May 7. Only candidates applying through our online recruitment system will be considered for this position. For more information please contact Karolin Isberg Jernby +46 (0) 703 551 459 We are looking forward to hearing from you! About Oticon MedicalOticon Medical is part of William Demant Holding with more than 12.000 employees across the world and revenues of over DKK 12 billion. Oticon Medical is the fastest growing manufacturer of bone anchored and cochlear implant hearing systems for children and adults.  At Oticon Medical we combine more than a century of experience in audiology and sound processing from Oticon with decades of pioneering experience in hearing implant technology. Our connection to Oticon gives us unique access to knowledge, resources and technology that we use for developing innovative and life-changing implantable hearing  


2765 Smorum Denmark

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