Quality System Specialist Global market leading IVD Company Hungary

Budapest - Hungary

Monthly Salary: Not Disclosed

Posted on: 17 hours ago

Vacancies: 1 Vacancy

Job Summary

On behalf of our client a global market leading IVD company we are looking for a fixed term (12 months) Quality System 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:

Bachelors 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 experience
Proactive can-do attitude with influencing/leadership skills detail-oriented and ability to multitask
Full working proficiency in Hungarian and English.
Proven experience working in GMP environment is a big plus
Understanding 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.