Quality Assurance Engineer
5 months ago
Are you excited by quality and compliance within the Medical Device industry? Are you a passionate people manager, keen to make your team grow and bloom? Do you want to be part of a pioneering Quality Management team, continuously setting the bar high in everything we do?
Then this might be your defining moment. Apply today and join us as Head of 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 CAPA/NCR Process and responsible for driving CAPA/NCR• Support to Planned deviations
• Support to Complaint handling and Complaint Process
• Support to PMS, trending and monitoring activities
• Perform training in general compliance processes
• 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 QAE Compliance & SQM
• Perform or support Quality Audits (Internal/External/Suppliers) according to audit plan or on request
• Responsible for Quality Assurance input to Supplier Controls: Evaluation; Monitoring; Re-evaluation
Suggested candidate profile
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:
Hvae a relevant academic background, BSc / MSc/ Engeneer 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 organizationAmbu – 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
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