Senior Quality Manager (m/w/d) Global OEM

  • Career level: Direct Entry
  • Employment: Fulltime, permanent
  • Start: 01-08-22
  • Location: Hamburg
  • Job-ID: R4835

Would you like to work for a company who has made it its mission to make a contribution to improving human living conditions? With around 4,500 employees worldwide Eppendorf is a leading Life Sciences company. We develop and distribute devices, consumables and services for use in laboratories worldwide. Our daily work is characterized by our principle: Collaborate on new ideas. You would like to take responsibility and help to make a difference in an experienced international company? Exciting tasks combined with a positive and affirmative working environment await you at Eppendorf. You are also motivated by technical challenges? Then apply now!

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Your challenges

  • You are the main contact person for OEM customers, the Technology Divisions and Centers as well as for the Business Partners of QM and Regulatory Affairs and help to build and maintain a "Quality Culture" in the respective OEM organizational units within Eppendorf.
  • You accompany customer projects during their entire life cycle in terms of quality, orchestrate the product change management and ensure a structured, transparent and compliant Post Market Surveillance for our OEM customers.
  • You will actively contribute to the standardization and harmonization of processes within Eppendorf's OEM business, ensure compliant documentation and execution of these processes, and take care of building and maintaining an E2E OEM process landscape to improve the understanding, performance and quality of the processes and their documentation
  • You are responsible for maintaining and improving the standardized and manageable quality management system processes for the Eppendorf OEM business (ISO 9001 / ISO 13485 / ISO/IEC 17025 and CFR 21 Part 820, GMP)
  • You are responsible for the ongoing review of specific requirements from the OEM products and/or processes in relation to company standards and derive recommendations for improvement
  • You will train OEM teams on relevant quality requirements and support the teams in identifying process failures and coordinate the overall risk management process along the value chain and risk assessment of business processes
  • You will be the point of contact for internal and external audits involving internal and external interface partners (including in customer audits, Technology Divisions, Logistics, etc.) and participate in the handling of deviations from the audits or other process deviations

Your expertise

  • You have successfully completed your studies (industrial engineering, mechanical engineering, chemistry, physics or similar).
  • You have several years of practical experience in quality management in international companies in the life science, medical technology or pharmaceutical industry or a similarly regulated industry.
  • You have experience in the maintenance and further development of a QM system and bring very good knowledge of quality management systems according to ISO 9001/ ISO 13485, ISO/IEC 17025 and ideally CFR 21 Part 820 and GMP.
  • You bring a strong technical understanding, desirably in the field of polymers and/or mechanical processing.
  • You enjoy interface activities with customers as well as other internal and external stakeholders
  • You have strong analytical and conceptual skills and use these, in addition to your good eye for detail, in the preparation of trend-setting decision documents and analyses
  • Ideally, you bring knowledge of Microsoft Dynamics 365 with you
  • Business fluent in both English and German round off your profile, other languages are also an advantage

Your benefits at Eppendorf

  • We really appreciate our employees and their performance. This is why we offer an attractive salary.
  • To enable you to deepen your technical knowledge and to continuous development we offer a wide range of trainings and development options.
  • By working for us you will make a meaningful contribution to improving human living conditions.
  • At our locations in Hamburg, Leipzig and Oldenburg i.H. you can also benefit from a subsidized lunch in the company restaurant.

Please note that we can only consider applications that are submitted online via our application management tool.

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