Quality Assurance Engineer

at  Ambu

Are you excited by 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 job opportunity that may be your next career move.
Apply today and join us as Quality Assurance Engineer in Global Quality Management Operations out of our HQ in Ballerup, Denmark!

KEY RESPONSIBILITIES

In this role, you will be part of a stellar team consisting of 8 talented QM professionals. Together, you will ensure quality and regulatory compliance of Ambu products and processes across the organization by continuously monitoring compliance via CA/PA, NCR, SQM etc.
This will include development and optimization of the Quality Management System and Processes within your team’s area of responsibility.

Your main responsibilities will include:

• Support to the CAPA/NCR Process
• Responsible for driving CAPA/NCRs with your business partners in Ambu
• Support to Planned deviations
• Perform training in general compliance processes when needed
• Perform training in CAPA/NCR process to Ambu business partners
• Overall improvement of the Quality System Performance within QA Processes
• Participate in global quality fora to discuss proactive process improvement
• Support other processes and tasks within QM Operation
• Support to Quality Assurance input to Supplier Controls: Evaluation; Monitoring; Re-evaluation

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 2-8 years’ experience working in a quality organization within Medical Devices
• Carry demonstrated experience with CAPAs, NCRs, SQM
• Have strong knowledge of relevant regulations for medical devices e.g., ISO13485, EU MDR, MDSAP, UK MD
• Have a passion for quality and focus on QM business partnering with the organizatio