Senior 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 Senior 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 of 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. This senior position will have different operational, support and improvement responsibilities, with further opportunities to impact the processes and development of QM Operations strategic journey.

Your main responsibilities will include:

• Responsible for driving CAPA/NCRs with your business partners in Ambu
• Overall improvement of the Quality System Performance within QA Processes
• Support and drive Quality Management Review process
• Perform training in general compliance processes
• Participate in global quality fora to discuss proactive process improvement

Other tasks that potentially be included:

• Support to PMS, trending and monitoring activities
• Support other processes and tasks within QM Operation
• Perform or support Quality Audits (Internal/External/Suppliers) according to audit plan or on request (if aspiration for or is a qualified auditor)
• Responsible for Quality Assurance input to Supplier Controls: Evaluation; Monitoring; Re-evaluation

Skills and experiences can be earned in many different 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 5-10 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 and relevant standards
• Have a passion for quality and focus on QM business partnering with the organizatio