Supplier-Quality-Management-%28SQM%29-Quality-Assurance-Engineer

Req ID: 9385

Are you passionate about quality and compliance within the Medical Device industry? Do you want to be a part of a global organization with high professional standards and a great working environment? Then we have an exciting new opportunity that be your next career move.

Apply today and join us as a Quality Assurance Engineer in Global Quality Management Operations, based at our HQ in Ballerup, Denmark.

Key responsibilities

In this role, you will be part of a great team of 11+ talented QM professionals. Your main task will be to drive our Supplier Quality Management (SQM) processes in collaboration with your colleagues in Global Quality Management Operations. This include supplier auditing, and developing and optimizing the SQM processes within your team’s area of responsibility.

To support our strategic journey in QM Operations, we are looking for a strong candidate to guide and contribute to the improvement of our Supplier Quality Management processes. You will work closely stakeholders in Global Quality Management - both corporate and local functions - as well as with Global Procurement.

Your main responsibilities will include:

• Driving Supplier Quality Control within Global Quality Management
• Managing Supplier Quality Agreements
• Overseeing supplier approvals, reevaluations, and monitoring
• Supporting supplier sourcing projects
• Executing supplier audits as Lead and/or co-auditor according to the audit plan
• Providing relevant data for Management Review and Quality reporting in collaboration with colleagues
• Collaborating closely with Global Procurement and Global Supply Chain on supplier quality issues, including reviewing supplier information and KPIs
• Participating in global quality forums to discuss proactive process improvements and supplier quality issues
• Continuously monitoring SQM processes for compliance and improvements opportunities

Additional tasks may include:

• Supporting other processes and tasks within QM Operations

Suggested candidate profile

Skills and experiences can be gained in several ways, and we understand that the best fit for the role can have relevant experience and competences from diverse areas. You are however likely to succeed in this position if you:

• Have a relevant academic background (BSc /MSc/Engineering)
• Bring around 5 years of experience in a quality organization within the Medical Devices industry
• Have demonstrated experience with Supplier Quality Management processes
• Hold ISO13485 Auditor/Lead Auditor Training
• Have competencies in IT supplier auditing and monitoring (e.g. knowledge within Information Security – ISO27001, NIS2)
• Posses strong knowledge of relevant medical devices regulations (e.g., ISO13485, EU MDR, MDSAP, UK MD and relevant standards)
• Are passionate about quality and committed to partnering with the business on QM initiatives

As a person, you are outgoing, eager to learn, and able to work both independently and in teams. You have strong collaboration and communication skills, and you're experienced in prioritizing tasks to meet deadlines. You can balance regulatory and business requirements across all kew responsibilities.

Since Ambu is a global company, proficiency in professional English is required.

What Ambu offers

• The chance to help shape a paradigm shift in the healthcare market
• An exciting role with innovative and groundbreaking medical device products
• A positive working atmosphere where the customer is at the center
• A collegial, friendly, and dynamic environment in a growing company
• An energetic team with short communication lines
• Competitive and performance-based remuneration
• Opportunities for personal and professional development
• The possibility to work from home up to two days per week

How to apply

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. If you are ready to apply, please do as soon as possible. We will invite candidates for interviews on a continuous basis.

If you have any questions about the position, fell free to contact Niels-Jørgen Svarrer, Head of Global Quality Management Operations and IT Compliance, at [email protected].

Your application will be treated with confidentiality.