Quality Management Specialist, Global QM 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

Quality Management Specialist, Global QM Sales & Distribution

City: Ballerup Country/Region: Denmark State: Business Area: Quality Assurance Department: Global Quality Management Sales & Distribution Employment Type: Full-time Req ID: 10431

Are you passionate about quality and compliance in a regulated environment?

Would you like to join a newly established Global Quality Management Sales & Distribution team at Ambu A/S and make a tangible impact across a global sales organization?

If so, this position as Quality Management Specialist, GQM Sales & Distribution might be your next career opportunity.

A global role with real impact

We are looking for a hands - on Quality Management Specialist to support compliance with regulated activities related to sales and distribution across Ambu's global subsidiaries.

You will become an integral part of an ongoing strategic initiative aimed at optimizing Ambu's operating model for regulated sales and distribution activities. In this role, you will help strengthen audit readiness, align local quality management systems with global standards, and support subsidiaries with practical, value - adding quality solutions.

You will report to the Head of Global Quality Management System, Sales & Distribution, and work closely with colleagues across Global Quality Management, Global Regulatory Affairs, and Global Sales.

Your key responsibilities

As part of a newly established global function, you will take on a hands - on, operational role from day one. Your responsibilities will include:

• Acting as compliance support and liaison between Global Quality Management and Ambu's Sales & Distribution organization
• Drafting,maintaining,and improving processesandQMS 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 harmonizationand 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

Your profile

Skills and experience can be gained in many ways. You are, however, likely to succeed in this role if you have:

• 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

Personally, you enjoy being operational and close to the business, taking ownership of your work, and are motivated by enabling quality and compliance through positive partnering.

Why join Ambu?

At Ambu, we believe that quality is an enabler of growth and trust. You will join a growing global quality function where you can influence how compliance is embedded into commercial operations - and where your work has a visible impact across the organization.

Ambu - a visionary and international workplace where your efforts matter

Ambu is a company that expands rapidly and has ambitious growth targets. We meet these targets through interdisciplinary teamwork between motivated and highly skilled employees. Your contributions and efforts are crucial to our success and by joining us you will get the opportunity to work in an international head office with an informal working environment.

We offer great opportunities for personal development. Furthermore, we offer a wide range of professional, social, and financial employee benefits in addition to exciting job challenges and continuous professional and personal development.

About Ambu

Ambu has been bringing the solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anaesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America and the Asia Pacific.

For more information, please visit ambu.com or follow us on LinkedIn .