Global QMS Specialist - Sales & Distribution

Ambu; Ballerup; On-site; DKK 550,000 - 750,000; Full time

Job summary

Ambu A/S seeks a hands-on Quality Management Specialist to support compliance for regulated activities in sales and distribution across its global subsidiaries. You will strengthen audit readiness, align local QMS with global standards, and provide value‑adding quality solutions.

You will report to the Head of Global Quality Management System, Sales & Distribution, and collaborate with Global Quality Management, Global Regulatory Affairs, and Global Sales to drive practical improvements.

Qualifications

• 2+ years of experience in Quality Management or QMS operations
• Practical experience writing SOPs and QMS documentation
• Familiarity with ISO 13485, EU MDR, and possibly MDSAP / UK MDR
• Experience collaborating with Sales organizations and/or distributors in a regulated environment is a plus
• Hands‑on experience handling and documenting quality cases

Responsibilities

• Act as compliance liaison between Global Quality Management and Ambu’s Sales & Distribution organization
• Draft, maintain, and improve QMS processes and documents for subsidiaries
• Support audit readiness and documentation for audits and inspections
• Assist harmonization and simplification of QMS across subsidiaries
• Support strategic projects to optimize the operating model for regulated sales and distribution

Skills

Quality Management

QMS operations

SOP writing

ISO 13485

EU MDR

MDSAP/UK MDR (plus)

Cross-functional collaboration

Quality cases handling

Job description

Ambu A/S seeks a hands-on Quality Management Specialist to support compliance for regulated activities in sales and distribution across its global subsidiaries. You will strengthen audit readiness, align local QMS with global standards, and provide value‑adding quality solutions.

You will report to the Head of Global Quality Management System, Sales & Distribution, and collaborate with Global Quality Management, Global Regulatory Affairs, and Global Sales to drive practical improvements.