Region QA & QMS Governance Manager (MedTech)

TL;DR

Region QA & QMS Governance Manager (MedTech): Leading and strengthening the Quality Management System (QMS) across assigned regions to ensure compliance with global medical device standards with an accent on regulatory alignment and systemic quality. Focus on harmonizing global QMS processes, managing audit readiness for regulators, and driving continuous improvements through CAPAs and KPIs.

Location: Stockholm, Sweden (Onsite)

Company

hirify.global is a mission-driven organization specializing in radiation therapy and oncology solutions to improve patient outcomes worldwide.

What you will do

• Lead and ensure effective implementation and compliance of the regional QMS aligned with global governance.
• Develop, maintain, and harmonize global QMS processes and strategic roadmaps.
• Coordinate internal audits and manage external audits with regulators and Notified Bodies to ensure certification readiness.
• Drive the management of audit findings, nonconformances, and CAPAs using root cause analysis.
• Monitor QMS performance through the establishment of KPIs, dashboards, and governance forums.
• Serve as the Subject Matter Expert for EDMS/eQMS tools, specifically MasterControl.

Requirements

• Extensive QA and/or Regulatory Affairs experience within medical devices or pharmaceuticals.
• Strong working knowledge of ISO 13485, EU MDR, MDSAP, and FDA QSMR.
• Qualified internal auditor status through formal training or equivalent professional experience.
• Proven expertise in document control, nonconformance management, and CAPA processes.
• Scientific university degree or equivalent relevant professional background.
• English: Excellent written and verbal communication skills are required.

Culture & Benefits

• Opportunity to significantly impact how quality systems are governed in a regulated global environment.
• Collaboration with senior stakeholders to shape the future of QMS governance.
• Ability to lead, coach, and prioritize work for regional QA and governance teams.
• Engagement with a mission-driven team focused on life-changing medical technologies.