Country: Hungary
Functional area: Quality Assurance & Quality Control
Our partner, a leading multinational company within the MedTech / Medical Device industry, is seeking a highly skilled and project-oriented professional to join their global QMS team.

 Key Responsibilities
  • Manage configuration changes and system updates on a project basis. Actively support the introduction and roll-out of new Veeva applications.
  • Lead and coordinate software testing and system validation processes, ensuring strict compliance with FDA software validation standards.
  • Maintain the digital quality system, manage the change control pipeline, and prioritize system modifications.
  • Act as the bridge between internal stakeholders
  • Work closely with Process Leads and Process Owners to understand their business needs.
  • Coordinate with the IT team, translating user change requests into technical execution.
  • Provide hands-on support for end-users, troubleshoot inquiries, and ensure the system meets both operational and project-specific governance requirements.
Requirements
  • Industry Experience: Proven background in a highly regulated industry, with a strong preference for the MedTech / Medical Device sector. Solid understanding of QMS processes in this environment is essential.
  • Technical Expertise: Direct experience in digital software system management, software testing, configuration change management, and system validation (FDA framework).
  • System Knowledge: Hands-on experience with the Veeva platform is a distinct advantage.
  • Language Skills: Professional fluency in English is mandatory. Hungarian language skills are not required.
  • Mindset: Strong problem-solving skills, exceptional attention to detail, and the ability to work effectively in a project-driven, global environment.
Compensation & Location
  • Global Environment: Opportunity to work in a truly international, cross-functional environment with global stakeholders. 
  • Hybrid Working Model: 3 days of Home Office per week with built-in flexibility.
  • Competitive Compensation: A seniority-based salary package combined with a performance bonus system and additional corporate benefits.

If the opportunity sounds interesting to you and you believe your professional experience is a good fit, please upload your English CV or contact me directly at zsbodi@carbyne.hu.
Our partner, a leading multinational company within the MedTech / Medical Device industry, is seeking a highly skilled and project-oriented professional to join their global QMS team.

 Key Responsibilities

  • Manage configuration changes and system updates on a project basis. Actively support the introduction and roll-out of new Veeva applications.
  • Lead and coordinate software testing and system validation processes, ensuring strict compliance with FDA software validation standards.
  • Maintain the digital quality system, manage the change control pipeline, and prioritize system modifications.
  • Act as the bridge between internal stakeholders
  • Work closely with Process Leads and Process Owners to understand their business needs.
  • Coordinate with the IT team, translating user change requests into technical execution.
  • Provide hands-on support for end-users, troubleshoot inquiries, and ensure the system meets both operational and project-specific governance requirements.

Requirements

  • Industry Experience: Proven background in a highly regulated industry, with a strong preference for the MedTech / Medical Device sector. Solid understanding of QMS processes in this environment is essential.
  • Technical Expertise: Direct experience in digital software system management, software testing, configuration change management, and system validation (FDA framework).
  • System Knowledge: Hands-on experience with the Veeva platform is a distinct advantage.
  • Language Skills: Professional fluency in English is mandatory. Hungarian language skills are not required.
  • Mindset: Strong problem-solving skills, exceptional attention to detail, and the ability to work effectively in a project-driven, global environment.

Compensation & Location

  • Global Environment: Opportunity to work in a truly international, cross-functional environment with global stakeholders. 
  • Hybrid Working Model: 3 days of Home Office per week with built-in flexibility.
  • Competitive Compensation: A seniority-based salary package combined with a performance bonus system and additional corporate benefits.

If the opportunity sounds interesting to you and you believe your professional experience is a good fit, please upload your English CV or contact me directly at zsbodi@carbyne.hu.