Quality Management System Lead

Our client is a strong international technology group with a global reach and offices in Europe and US. For one of their subsidiaries, an AI technology company operating in the healthcare industry and developing Software As A Medical Device, we are looking for an experienced:

Quality Management System Lead


• Work with external consultants and vendors to develop, implement and execute a new eQMS.
• Prepare and implement internal policies and SOPs.
• Prepare and implement adequate Document, Design and Change Request Controls as well as processes for Non-Conformities and CAPAs.
• Provide internal QMS training to all staff.
• Organise both internal and external audits and support audit readiness (ISO 13485, FDA 21 CFR 820 and MDR).
• Act as the ISO and Regulatory standard Management Representative.
• Continuously maintain and improve QMS.


• 3+ years of Quality Management experience in the healthcare industry.
• Previous experience in implementing or developing a Quality Management System.
• Proven knowledge of ISO13485.
• Ability to continually evaluate the quality systems and maintain complete documentation to ensure the necessary controls are in place.
• Highly developed communication and organizational skills.
• Ability to drive changes and inspire others to generate new ideas.
• Fluent in English.

Should you consider yourself as the right candidate for this role, we would be glad to receive your CV in English.

Only shortlisted candidates will be contacted by our consultants.

Applying for this position, you are authorizing Novi Global to work and process with your personal information following the Law for Personal Data Protection.

Agency license Number 2123 issued on 04.10.2016.
Job Type:
Job Title:
Quality Management System Lead
Bulgaria - Sofia

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