Quality System Specialist Global market leading IVD Company Hungary
5 days ago
On behalf of our client, a global market leading IVD company, we are looking for a fixed term (12 months) Quality System Specialist.This Specialist role will be responsible for assisting in the collection and reporting of Quality data, as well as producing periodic post-market surveillance reports for products.
As Quality System Specialist, your key tasks will include:
Provide ongoing maintenance and support for databases and systems essential for tracking various post-market surveillance activities within the quality management system (QMS).Conduct post-market data analysis and collaborate with business partners to review finalized reports.Ensure the retention and organization of controlled quality records.Contribute to a range of QMS and PMS projects, both at the local and global levels, as required.Manage the coordination of post-market surveillance (PMS) and post-market performance follow-up (PMPF) deliverables in collaboration with internal business partners.Facilitate and/or chair local/regional PMS Board meetings.Support internal/external audits as needed.Undertake additional responsibilities and tasks as the situation demands.We are looking for the following background:
Bachelor's degree or equivalent in a related life science/technical/engineering discipline or equivalent preferred.2+ years experience in a regulated manufacturing industry or equivalent combination of education and experienceProactive, can-do attitude with influencing/leadership skills, detail-oriented and ability to multitaskFull working proficiency in Hungarian and English.Proven experience working in GMP environment is a big plusUnderstanding of product post market surveillance requirements for IVD products is a plus.Experience with electronic Quality Management Systems (QMS) such as Veeva, EtQ, or Trackwise is a valuable asset.Should you be interested in the details of this vacancy feel free to leave a comment with your details or submit your CV for this role.
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