Supplier Quality Management (SQM) - Quality Assurance Engineer

Ambu; Augsburg; Hybrid; EUR 60.000 - 80.000; Vollzeit

Benefits dieser Stelle

Hybrid work model

International environment

Competitive compensation

Development opportunities

Zusammenfassung

Ambu is seeking a Quality Assurance Engineer to join our Global Quality Management Operations. This role can be based at Augsburg, Germany, or Ballerup, Denmark, with a hybrid model (three days in office, two days home).

You will drive Supplier Quality Management processes, oversee supplier approvals and audits, and collaborate with Global Procurement and Supply Chain to ensure quality and compliance across our global operations. English proficiency is required.

Qualifikationen

• Bachelor or higher in Engineering, Quality, Life Sciences.
• Hands-on experience in Supplier Quality Management within Medical Devices.
• ISO 13485 Auditor training or certification.

Aufgaben

• Drive and continuously improve Supplier Quality Management (SQM) processes.
• Oversee supplier approvals, re-evaluations and ongoing performance monitoring.
• Lead or participate as Lead Auditor/Co-Auditor in supplier audits.
• Provide data and insights for Management Reviews and KPI reporting.
• Collaborate with Global Procurement and Supply Chain on supplier quality topics.

Kenntnisse

Quality Assurance

Supplier Quality Mgmt

ISO 13485 Auditor

Auditing

Regulatory knowledge

English proficiency

Cross-functional collaboration

Lead Auditor

Ausbildung

BSc/MSc in Engineering or Life Sciences

Tools

Audit management tools

Jobbeschreibung

Are you passionate about quality, supplier excellence, and compliance in the Medical Device industry? Do you thrive in a collaborative international environment where quality is at the heart of everything we do? If so, this could be the next exciting step in your career. At Ambu, we are looking for a Quality Assurance Engineer to join our Global Quality Management Operations team. This position can be based either at our headquarters in Ballerup, Denmark, or at our site in Augsburg, Germany. We believe that great work happens when talented people are empowered to perform at their best.

That's why we offer a hybrid working model with three days in the office and two days working from home, giving you the flexibility to balance collaboration and focus.

If you're looking to make a meaningful impact in a global MedTech company that is improving patient care through innovation, we'd love to hear from you.

Key Responsibilities

As part of our team of 11+ dedicated Quality Management professionals, you will play a key role in driving and continuously improving our Supplier Quality Management (SQM) processes.

You will work closely with colleagues across Global Quality Management Operations, Corporate Quality, local quality functions, Global Procurement, and Supply Chain to ensure supplier quality and compliance throughout our global operations.

Your Main Responsibilities Will Include

• Driving Supplier Quality Control activities within Global Quality Management
• Managing Supplier Quality Agreements
• Overseeing supplier approvals, re-evaluations, and ongoing performance monitoring
• Supporting supplier sourcing and qualification projects
• Planning and conducting supplier audits as Lead Auditor and/or Co-Auditor
• Providing relevant data and insights for Management Reviews and Quality reporting
• Collaborating closely with Global Procurement and Supply Chain on supplier quality topics, performance reviews, and KPIs
• Participating in global quality forums to discuss supplier quality performance and drive continuous improvement initiatives
• Monitoring SQM processes to ensure compliance, effectiveness, and ongoing optimization

Additional Responsibilities May Include

• Supporting other processes and activities within Global Quality Management Operations
• Contributing to cross-functional quality improvement projects and strategic initiatives

Suggested Candidate Profile

We know that talented professionals come from a variety of backgrounds and experiences. While there is no single path to success in this role, we believe you will thrive if you bring several of the following qualifications:

Qualifications

• A relevant academic background within Engineering, Quality, Life Sciences, or a related field (BSc, MSc, or equivalent)
• Relevant experience in a quality-focused role within the Medical Device industry
• Hands-on experience with Supplier Quality Management processes
• ISO 13485 Auditor or Lead Auditor training
• Experience with IT supplier auditing and supplier monitoring activities, ideally including knowledge of Information Security standards such as ISO 27001 and NIS2
• Strong knowledge of relevant Medical Device regulations and standards, including ISO 13485, EU MDR, MDSAP, UK Medical Device regulations, and related quality standards
• A genuine passion for quality and a proactive approach to partnering with the business to drive quality initiatives
• As a person, you are collaborative, curious, and motivated to learn. You enjoy working with diverse stakeholders, can balance multiple priorities, and communicate effectively across different levels of the organization. You are comfortable navigating both regulatory requirements and business needs while maintaining a strong focus on quality and compliance.
• As Ambu is a global organization, professional proficiency in English is required.

What Ambu Offers

Joining Ambu means becoming part of a company that is challenging conventions and helping shape the future of healthcare.

We Offer

• The opportunity to contribute to a paradigm shift in the healthcare market
• A meaningful role supporting innovative and market-leading medical device solutions
• An inclusive, international, and collaborative work environment
• A strong culture of teamwork, trust, and open communication
• A skilled and supportive global team with short decision-making paths
• Competitive compensation and benefits
• Excellent opportunities for professional and personal development
• A hybrid work setup with three days in the office and two days working from home
• The flexibility to be based in either Ballerup, Denmark, or Augsburg, Germany

At Ambu, we are committed to creating an inclusive workplace where everyone has the opportunity to succeed. All qualified applicants will receive consideration regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, or disability.