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QA Specialist

QA Specialist

Ferrosan Medical Devices A/S is looking for a highly professional, committed and motivated QA Specialist. 
Do you have experience with GMP, ISO 13485 and 21 CFR Part 820, wants to join a dynamic QA team and thrive working inter-organizational, this position may be for you. 

Your role 
As QA Specialist you will together with your QA colleagues support our on-site production and rest of the organization in quality and batch release. You will regularly have contact to our contract manufacturers and external partners. Among many versatile tasks you are responsible for review and approval of:

  • Change records
  • Deviations and CAPAs
  • Qualification and validation documentation 
  • Risk management and risk analysis 
  • Optimization of the Quality Management System 
  • Furthermore you must handle complaints, maintain master documentation (e.g. master batch records and specifications) and be QA representative in projects to continue developing of our products and optimizing our production.   

Your profile
We are looking for a committed, motivated, positive and highly quality minded person. In order to succeed in the job it is required that you are flexible, pragmatic, structured, able to prioritize and manage multiple task within deadlines. You are responsible and work independent in a dynamic and challenging environment. You are able to make fast decisions, communicate clearly and have good interpersonal skills. You thrives working with a combination of projects and system tasks related to manufacturing of medical devices and combination products (medical devices combined with medical drug).

  • Hold a Master of Science in Pharmacy or equal relevant education in Life Science
  • Minimum 2 years´ practical experience with GMP and/or ISO 13485 and 21 CFR Part 820
  • Flair for IT. Knowledge to SAP is an advance 
  • Fluent in Danish and English 

Working at Ferrosan Medical Devices
Ferrosan Medical Devices A/S has 190 employees covering all aspect of tasks related to production and release of medical devices and combination products. In the QA department we are 9 employees (specialists and technicians). We collaborate closely with our colleagues and the rest of the organization involved in the process flow from receipt of raw materials to the finished products released to market. LEAN principles are implemented as a natural part of our daily work. Beside our on-site production, contract manufacturers are used for sub-processes. Continue optimization of our system, processes and expansion of our product pipeline demands QA’s involvement in projects and opportunity for innovation.
We offer an exciting and challenging job in an international organization in growth. Ferrosan Medical Devices A/S is driven by a dedicated energetic organization succeeded with impressive growth.   

Please submit your application including CV no later than 3rd of August 2018 to job@ferrosanmd.com. Mark the application "QA Specialist". Submit in Danish or English no preference. Review of applications will be conducted on an on-going basis.                                     If you have any questions to the position please do not hesitate to contact QA Manager Naja Kundby (70252860).

Ferrosan Medical Devices A/S Biomaterials develops and manufactures absorbable gelatin products and combination products for haemostatic use during surgery. The products are marketed and distributed in more than 100 countries by our partner Ethicon Biosurgery, a part of Johnson & Johnson. We are 190 employees located in Søborg. www.ferrosanmedicaldevices.com

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