Job ID: 11812

Manager (m/w/d) Quality Assurance



Ihre Aufgaben.

In this role, you are managing the QA department of our client. You are setting the direction for achieving added value and securing/maintaining compliance according to CDD Quality Policy and by implementing and executing various QM processes throughout all different departments according to international standards and regulations (ISO 13485, MDSAP, 21 CFR 820). In addition to this, you are supporting supplier audits/assessments and support all the Quality agreement processes with various world-wide external partners.

  • Setting up the strategy for and ensuring that quality processes are established, implemented and maintained at all levels within the organization required by the latest valid versions of ISO 13485, MDSAP, 21 CFR 820, IVDD 98/79 being substituted until 2022 by IVDR 2017/746/EC, local and other international standards.
  • Ensuring by QA organization that adequate quality advice and guidance is provided to all departments.
  • Ensuring training tools are established and training is performed for all employees working within the quality management system.
  • Ensuring processes and compliant infrastructure regarding quality documents and records are established and maintained.
  • Monitoring, evaluating and reporting the effectiveness of the Quality Management System and its processes regarding suitability, adequacy and effectiveness; initiating measures where required.
  • Ensuring that internal audit concept is established and executed accordingly to the yearly planning cycle.
  • Establishment and management the various key elements of QMS as corrective and preventive action system, deviation process, process regarding non-conforming material and risk management process.
  • Provide strategy for management of Change Control Process to reflect all possible impacts of a change and to adhere to all world-wide compliance aspects.
  • Reporting on the performance of the quality management system and any need for improvements to the Executive Management Team (MTM) twice a year.

Ihr Anforderungsprofil.

  • Minimum Bachelor’s degree is required, preferably in a science or engineering discipline.
  • Experience in a manufacturing environment and with administering different quality systems.
  • Experience as a people leader.
  • Knowledge and direct experience working with ISO standards (ISO 13485, MDSAP, 21 CFR 820, additional national standards, IVDD/ IVDR).
  • Knowledge of process validation, change control, auditing quality management systems.
  • Skilled at analyzing data and summarizing results, as well as generating performance metrics to drive improvement.
  • Detail-oriented, organized and accurate; successful with influencing and driving results.
  • Strong ability to prioritize to meet objectives.
  • Strong written and oral communication skills, with the ability to collaborate and communicate effectively both externally and throughout the organization in German and English.


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