Job ID: 11704

Manager (f/m/d) Quality Control

Stellenart.

Keine Angaben

Ihre Aufgaben.

In this position, you are leading the Quality Control department and set the direction for achieving added value by implementing and following various QC processes according to international standards and regulations

  • lead and manage the team regarding effectiveness and efficiency.
  • evaluate and verify employee performance through the review of completed work assignments and achieved objectives.
  • You secure compliance of Quality Control practice to SOPs, establish structures to keep all documents lean and updated and to perform internal quality checks of procedures, reagents and instruments according to BRAHMS‘ Quality Management System.
  • You ensure that quality control processes are established, implemented and maintained within the organization as the need arises by standards and regulations e.g. ISO 13485, 21 CFR 820, IVDR 2017/746.
  • Participate in internal and external audits according to schedule.
  • act as primary liaison for QC topics between CDD Hennigsdorf and CDD Nimes as well as other Corporate partners worldwide.
  • identify training needs, develop training concepts and manage trainings for QC related processes
  • participate in projects related to product, processes or infrastructure topics on a as needed base as team member but as well as project manager.

Ihr Anforderungsprofil.

Education

  • Minimum B.A. or B.S. degree in Life Sciences field or comparable education. High school diploma or equivalent required.

Experience

  • Leadership experience paired with the ability to empower and support the team.
  • Sound experience in a Quality Control function, Certified Quality Manager or Quality Auditor preferred
  • Several years of laboratory experience in context of QC testing and release processes.

Knowledge, Skills, Abilities

  • Excellent knowledge of GMP, ISO 13485, 21 CFR 820 ideally in IVD environment.
  • Knowledge in medical terminology, quality management, QC processes and international quality management regulations.
  • Strong interpersonal skills as Manager to be able to work on exciting and resource-critical projects.
  • Proficiency to understand and assess processes and interfaces in and with other departments.
  • Sophisticated knowledge of MS Office and Document Management Systems.
  • Business Fluent in English and German, French is a plus.

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