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9 часов назад

Sr. Service Documentation Specialist (Medtech)

Формат работы
hybrid
Тип работы
fulltime
Грейд
senior
Английский
c1
Страна
Poland
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR

Sr. Service Documentation Specialist (Medtech): Managing the lifecycle of service checklist documentation and coordinating between Field Service, Legal Manufacturers, and Quality teams with an accent on QMS compliance and document control. Focus on managing change requests, ensuring audit readiness, and overseeing documentation workflows within a regulated medical device environment.

Location: Must be based in Plewiska, Poland (Hybrid: 3-4 days remote)

Company

hirify.global is a global provider of innovative medical technology solutions for healthcare and life sciences.

What you will do

  • Manage the end-to-end lifecycle of service checklist documentation, including release, publication, and archival.
  • Act as the primary liaison between Field Service, Legal Manufacturers, and Quality departments.
  • Coordinate change requests, ensuring all updates align with QMS and document control requirements.
  • Plan and prioritize workload for documentation resources while providing day-to-day guidance.
  • Maintain revision control and ensure documentation remains audit-ready and compliant.
  • Support global CAPA activities as an owner or action owner related to service quality.

Requirements

  • 3–5 years of experience in documentation, document control, or quality systems within regulated environments.
  • Strong understanding of QMS and document control requirements.
  • Proven experience coordinating activities across multiple stakeholders.
  • Excellent written and verbal English communication skills.
  • Proficiency with document management systems and Microsoft Office Suite.
  • Must be based in or able to work from Plewiska, Poland.

Nice to have

  • Experience in the medical device industry.
  • Experience supporting audits and compliance activities.
  • Proficiency with M-Files.

Culture & Benefits

  • Hybrid work model with 3-4 days of remote work per week.
  • Opportunity to work in a regulated, high-impact medical technology environment.
  • Focus on continuous improvement and digitalization initiatives.
  • Collaborative team environment with cross-functional stakeholder engagement.

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