Global Quality Lead, Sales & Distribution

Ambu A/S; Ballerup Kommune; On-site; DKK 447,761 - 671,642; Full time

Job summary

Ambu A/S seeks a hands-on Quality Management Specialist for the Global Quality Management Sales & Distribution team in Denmark. You will support compliance across Ambu's global subsidiaries, strengthening audit readiness and aligning local QMS with global standards.

You will work with Global Quality Management, Regulatory Affairs, and Global Sales to optimize the operating model and ensure effective implementation of decisions.

Qualifications

• 2+ years of experience in Quality Management or QMS operations.
• 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.
• 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

• Acting as compliance support and liaison between Global Quality Management and Ambu's Sales & Distribution organization.
• Drafting, maintaining, and improving processes and QMS documents specific for the subsidiaries.
• Handling and following up on quality cases in the Quality Management System (e.g. CAPAs and change controls).
• Supporting subsidiaries with audit preparation, including documentation readiness and best-practice material such as storyboards.
• Supporting harmonization and simplification of QMS across subsidiaries.
• Support strategic projects focusing on optimizing the operating model to ensure effective implementation of agreed decisions.
• Presenting documentation within your area of responsibility during audits and inspections of Ambu A/S.

Skills

Quality Management

QMS operations

SOP documentation

ISO 13485

EU MDR

MDSAP/UK MDR

Cross-functional collaboration

Audit readiness

Job description

Ambu A/S seeks a hands-on Quality Management Specialist for the Global Quality Management Sales & Distribution team in Denmark. You will support compliance across Ambu's global subsidiaries, strengthening audit readiness and aligning local QMS with global standards.

You will work with Global Quality Management, Regulatory Affairs, and Global Sales to optimize the operating model and ensure effective implementation of decisions.