Senior QM R&D Engineer - Risk Management

Ambu A/S; Ballerup Kommune; On-site; DKK 522,388 - 671,642; Full time

Benefits offered by this job

Opportunities for personal and professional development

Dynamic and diverse work environment

Wide range of employee benefits

Job summary

Ambu A/S is seeking a Senior Quality Management R&D Engineer in Ballerup, Denmark. This role focuses on driving risk management and quality assurance for medical device development, requiring a strong foundation in quality and compliance.

The ideal candidate should have a BSc/MSc with over 3 years in a regulated industry, excellent communication skills, and experience in quality engineering. Join a dynamic team at a leading medical device company dedicated to innovation and collaboration.

Qualifications

• 3+ years of experience in a regulated industry (medical devices or pharma).
• In-depth knowledge of quality standards applicable to medical devices.
• Experience in R&D projects of medical devices.

Responsibilities

• Drive Risk Management for both new and existing products.
• Serve as the Quality Management partner for global R&D projects.
• Carry out Life Cycle Management activities.
• Support non-conformities and CAPA activities.

Skills

Risk Management

Quality Engineering

ISO 14971

ISO 13485

EU MDR

Communication Skills

Education

BSc/MSc in a relevant field

Job description

City: Ballerup, Augsburg

Country/Region: Denmark, Germany

State:

Business Area: Quality Assurance

Department: Global Quality Management R&D

Employment Type: Full-time

Req ID: 10344

Senior Quality Management R&D Engineer

Risk Management

Shape the Future of Medical Innovation

Are you passionate about quality and compliance in medical device development? Do you have extensive experience in Quality Management across the product lifecycle— especially in Risk Management? If you're ready to lead global R&D initiatives and drive continuous improvement, your next career move could be with Ambu.

Why Join Ambu?

Ambu is a global leader in medical device innovation, dedicated to improving patient care. As a (Senior) QM R&D Engineer, you’ll be part of a collaborative, forward-thinking team that values integrity, innovation, and impact.

Join a Team That Thrives on Collaboration and Diversity

We offer a dynamic and supportive team environment where mutual trust and collaboration are at the heart of everything we do. Our team brings together talented professionals from across the globe, creating a truly international workplace that values different perspectives and fosters innovation. If you are looking for a role where teamwork, inclusivity, and shared success define the culture, this is the place for you.

You’ll join a growing team of more than 40 quality engineers based in Ballerup, Denmark, Augsburg, Germany and Penang, Malaysia, with this role located in Augsburg, Germany or Ballerup, Denmark.

Key responsibilities

• Driving Risk Management for both new and existing products
• Being the Quality Management partner for global R&D projects
• Carry out Life Cycle Management activities, including design changes and post-market surveillance
• Supporting non-conformities and CAPA activities

Suggested candidate profile

Skills and experiences can be earned in many ways, and we understand that the best fit for the role cannot be prescribed on paper. You are however likely to succeed in this position if you have a strong foundation in quality and a proactive mindset. Depending on your previous experience this role can also be a Senior position. Ideally, your profile includes:

• A BSc/MSc in a relevant field and 3+ years of experience in a regulated industry (medical devices or pharma)
• In-depth knowledge of standards such as ISO 14971, ISO 13485, EU MDR, MDSAP, and UK MD
• Experience as a Quality Engineer in Research & Development projects of medical devices
• Strong communication skills and the ability to translate quality requirements into actionable strategies
• A collaborative, open-minded approach with the confidence to drive and adapt in a fast-paced environment

We offer

• A great Team that thrives on collaboration and values different perspectives and fosters innovation
• Opportunities for personal and professional development
• A dynamic, diverse and international work environment
• A wide range of employee benefits—professional, social, and financial

As an equal opportunity employer, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin.