Senior Quality Assurance Engineer

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 a new exciting job opportunity that may be your next career move.

Apply today and join us as Senior Quality Assurance Engineer to take responsibility for our CAPA Process. This new position is placed in Deviation Controls & Reporting (Global Quality Management Operations, QM) out of our site in HQ in Ballerup, Denmark.

Key Responsibilities
In this role, you will be part of a small team consisting of currently 5 talented Quality Management professionals. Your main task will be to drive and maintain the CAPA process pertaining to compliance of Ambu products with relevant stakeholders in Ambu globally. In close connection with this process, you will also be involved in securing quality and regulatory compliance of Ambu products and processes across the organization.

This will include development and optimization of the Quality Management System and Processes within your team's area of responsibility. This position will have different operational, support and improvement responsibilities, with further opportunities to impact on the processes and development of QM Operations strategic journey.

Your Main Responsibilities Will Include

• Process owner for the CAPA process across the global organization.

Tasks Will Include

• Cross-functional teamwork for handling non-conformities
• Drive Corrective and Preventive Actions for Ambu A/S HQ and support our Local Productions sites, in Penang (Malaysia), Xiamen (China), Juarez (Mexico) and Noblesville (USA).
• Communication to Management and other relevant stakeholders
• Engage in global quality forums to promote proactive process improvements and provide support to local manufacturing sites.
• Driving monitoring quality issues across interconnected processes in order identify potential quality action, for example through customer complaints.
• Driving updating and revising SOPs related to the processes

Other Tasks That Potentially Be Included
Support other processes and tasks within QM Operation, for example optimizations projects.

Suggested candidate profile
Skills
Skills and experience 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 relevant academic background, BSc / MSc/ Engineer
• Have at least 5-8 years' experience working in a quality organization within Medical Devices
• Experience with CAPAs, NCRs, LEAN and project management.
• Have strong knowledge of relevant regulations for medical devices e.g., ISO13485, EU MDR, MDSAP, UK MD and relevant standards
• Have a passion for quality and focus on QM business partnering with the organization
• English is the corporate language, which requires that you speak and write English at a high level.

You are an outgoing and open-minded individual who thrives on learning and development. Whether working independently or as part of a team, you bring a strong sense of responsibility and collaboration. You take pride in respectful dialogue and positive interactions with colleagues across a global organization.

You are structured and methodical, with a strong ability to prioritize, plan, and see tasks through completion. You consistently demonstrate a good balance between business needs and regulatory requirements across all key responsibilities.

In addition, you are a sharp and reliable reviewer with a keen eye for detail, ensuring high quality and accuracy in all deliverables.

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.

When 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 for the position, please apply as soon as possible. We will invite candidates for interviews on a continuous basis so there is no need to hesitate.

If you have any questions about the position, you can contact Nina Brink Katz, Quality Manager, Deviation Controls & Reporting

• Global Quality Management Operations