Global QMS & Compliance Specialist (Sales & Distribution)

Ambu A/S; Denmark; On-site; DKK 600,000 - 800,000; Full time

Job summary

Ambu A/S is seeking a Quality Management Specialist in Denmark, based in Ballerup, to support the Global Quality Management Sales & Distribution function. The role focuses on compliance for global subsidiaries and strengthening audit readiness across a regulated sales and distribution environment.

You will work with Global Quality Management, Global Regulatory Affairs, and Global Sales to align local QMS with global standards and deliver practical quality solutions across the organization.

Qualifications

• 2+ years of experience in Quality Management or QMS operations
• Practical experience in 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 would be a plus
• Hands - on experience handling and documenting quality cases
• A pragmatic, solution - oriented mindset with strong attention to detail
• Strong collaboration skills in a global setting
• Confidence communicating with colleagues across functions, cultures, and seniority levels

Responsibilities

• Act as compliance liaison between Global Quality Management and Ambu's Sales & Distribution
• Draft, maintain and improve processes and QMS documents for subsidiaries
• Handle and follow up on quality cases in the Quality Management System (CAPAs and change controls)
• Support subsidiaries with audit prep and documentation readiness
• Support harmonization and simplification of QMS across subsidiaries
• Support strategic projects to optimize the operating model for effective implementation
• Present documentation during audits and inspections at Ambu A/S

Skills

Quality Management

QMS operations

SOPs

ISO 13485

EU MDR

MDSAP/UK MDR

Sales collaboration

Quality cases

Attention to detail

Global collaboration

Job description

Ambu A/S is seeking a Quality Management Specialist in Denmark, based in Ballerup, to support the Global Quality Management Sales & Distribution function. The role focuses on compliance for global subsidiaries and strengthening audit readiness across a regulated sales and distribution environment.

You will work with Global Quality Management, Global Regulatory Affairs, and Global Sales to align local QMS with global standards and deliver practical quality solutions across the organization.