According to kununu users, this is what you could earn as a Qualitätsmanager:in in Austria.
The Position
The role champions a culture of quality throughout the FWC Africa markets by leading a robust quality assurance program, ensuring strict compliance, and effectively managing any emergent quality and product safety issues.
Main Responsibilities
- Network quality management review: Reporting on quality performance, monitoring Quality-KPIs, and conducting management reviews per ISO 13485 requirements.
- Quality system management: Managing the QMS, ensuring adherence to international standards and Roche policies, and facilitating training on quality processes.
- Management of External Business Partners: Overseeing the quality lifecycle of partners, including supplier qualification, contract management, and 3PL operations oversight.
- Risk management: Integrating Quality Risk Management into business processes and conducting annual risk evaluations.
- Change control: Ensuring compliance with change control processes for planning and implementing changes.
- Document control: Managing document management systems, maintaining SOPs and policies, and ensuring timely approval workflows.
- Operational QA management: Overseeing logistics, shipment, product integrity, and cold chain management.
- Local Safety Officer: Overseeing complaint management system compliance and case quality reviews.
Who you are
Required Experience and Education: Bachelor’s degree in a health science related field, bilingual in English and French, 2-3 years of experience in the medical device/IVD industry, and 2-3 years of management experience. Must have knowledge of pharmaceutical regulations and QA principles.
Required Competencies and Skills: Achieving results, strategic agility, political savvy, relationship management, teamwork and collaboration, communication, problem solving, and situational responsiveness.
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