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Quality Assurance Manager for Consumables (EW)

Engineering
Risch
English

Are you ready for a new challenge? Are you a proactive Quality Assurance Manager? Then this role is for you!In this interesting role as a Quality Assurance Manager, you are working for a Pharma / Medical diagnostic company that offers solutions to health care, with a global presence. Tasks & Responsibilities

  •  Support and enable the business partners regarding product care and product improvement activities as well as in all other quality aspects of the consumables products
  •  Ensure product quality and compliance with the regulatory requirements and the proper documentation of all activities
  •  Support our business partners by reviewing and approving projects-, products- and process documents, changes and deviations, Q&V activities, and releasing products
  •  Ensure improvements through CAPAs, SCARs, and process updates
  •  Lead and/or support special projects or initiatives in the area of quality and of our business partners
  • Permanently optimize processes in order to increase quality and efficiency standards

 Must Haves

  •  Academic degree in an engineering or life science discipline or related work experience in Quality Management 
  •  Min. 3+ years experience with the medical device regulations including ISO 13485 and FDA regulations for the above-mentioned processes 
  •  Min. 3+ years experience in Quality Management, Quality Assurance, or Quality Control, preferred in the medical device industry at least in the regulated industry 
  •  Technical and/or scientific understanding to be able to work with Business and Technical stakeholders
  •  Hands-on experience in leading a process improvement project 
  •  Fluency in German and English, spoken and written (min. B2 Level in both languages)
  • Strong communication skills
  •  od stakeholder management skills across all hierarchy levels
  •  Self-dependent, structured, quality-oriented, and determined
  • Solution-oriented mindset, active and initiative personality
  •  A crucial contribution to the spirit of the existing team

 Nice to Haves

  • SAP Skills
  •  Kledge of Injection Molding

 We are looking forward to your application. od luck