Quality Assurance Specialist

1 week ago

Ballerup, Ballerup Kommune, Denmark Ambu Full time

Are you passionate about ensuring excellence and adherence to standards in the Medical Device sector? Do you possess a strong leadership ability to nurture and develop your team? If so, this could be a pivotal opportunity for you.

Key Responsibilities

In this position, you will collaborate with a skilled team of 8 quality management experts. Your collective goal will be to uphold quality and regulatory standards for Ambu's products and procedures throughout the organization by consistently assessing compliance through CA/PA, NCR, SQM, and more.

Your primary duties will encompass:

  • Facilitating the CAPA/NCR Process and leading the execution of CAPA/NCR initiatives
  • Assisting with Planned Deviations
  • Supporting the Complaint Handling and Complaint Process
  • Engaging in PMS, trending, and monitoring activities
  • Conducting training on general compliance procedures
  • Enhancing the performance of the Quality System within QA Processes
  • Participating in global quality forums to discuss proactive improvements
  • Supporting various processes and tasks within QAE Compliance & SQM
  • Executing or assisting with Quality Audits (Internal/External/Suppliers) as per the audit schedule or upon request
  • Providing Quality Assurance insights for Supplier Controls: Evaluation, Monitoring, and Re-evaluation

Ideal Candidate Profile

We recognize that skills and experiences can be acquired through various avenues, and the ideal candidate may not fit a specific mold. However, you are likely to excel in this role if you:

  • Hold a relevant academic qualification, such as a BSc, MSc, or Engineering degree
  • Have 2-8 years of experience in a quality-focused role within the Medical Devices industry
  • Possess proven experience with CAPAs, NCRs, and SQM
  • Have a solid understanding of pertinent regulations for medical devices, including ISO13485, EU MDR, MDSAP, and UK MD
  • Demonstrate a strong commitment to quality and a focus on quality management collaboration within the organization

About Ambu

Ambu is a rapidly growing company with ambitious goals. We achieve these objectives through collaborative efforts among our motivated and highly skilled workforce. Your contributions are vital to our success, and by becoming part of our international headquarters, you will experience a dynamic and informal work environment.

We provide excellent opportunities for personal growth and a comprehensive range of professional, social, and financial benefits, alongside exciting challenges and ongoing professional and personal development.

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