City: Ballerup
State:
Country: Denmark
Business Area: Quality Assurance
Department: Global Supply Chain
Employment Type: Full-time
Do you want to develop and manage QA process in AMBUs Global Supply Chain, and do you have an eye for detail and understand the importance of working in a regulated environment? Do you thrive in juggling many stakeholders?
Job Summary:
We are seeking a highly motivated and experienced Quality Assurance specialist to join our dynamic team. The ideal candidate will be responsible for maintaining a robust Quality Management System while driving continuous improvement across the functions in Global Supply Chain. This role will be pivotal in ensuring compliance with relevant regulatory standards and fostering a culture of quality within our organization. The primary focus will be on managing and developing the Quality Handbooks (QHBs), DEVs, SCO´s CAPAs and at the same time be go to for GSC in terms of Compliance related questions.
Main responsibilities:
- Create, manage and own CAPAs, NCRs, DEVs, SCOs, and DCOs as needed, ensuring thorough investigation and effective corrective and preventive actions.
- Ensure relevant updated QHBs are accessible and understood by all relevant personnel.
- Manage revisions and updates QHBs.
- Assure audit and inspection readiness and support NCRs, CAPAs, DEVs.
- Develop and maintain position based QHB training.
- Participate in change management projects and representing the QA process.
- Agile Superuser.
Area of responsibility:
- Drive and develop compliance structure and culture.
- E2E responsible Supply Chain QA projects in the role of project lead /key resource.
- Develop, implement, and maintain Supply Chains Quality Handbook, ensuring it aligns with current regulatory requirements (e.g., ISO 13485).
- Implement best practices, provide training and transfer knowledge from QA to GSC.
- Act as a key link between the Quality Assurance department and Global Supply Chain.
- Ensure compliance with audit requirements and implement corrective actions as needed.
Qualifications:
- Minimum 3 years of experience in a Quality Assurance role within the medical device industry.
- Understanding of ISO 13485, and other relevant regulatory standards.
- Bachelor's degree in a relevant scientific or engineering discipline.
- Proven experience in developing and managing Quality Management Systems.
- Experience with QMS methodologies and their application.
- Excellent communication, interpersonal, and problem-solving skills.
- Strong attention to detail and ability to manage multiple priorities.
- Strong business acumen and ability to transform operational solutions to relevant documentation.
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.
About Ambu
Ambu has been bringing the solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anaesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America and the Asia Pacific.
For more information, please visit ambu.com or follow us on LinkedIn.
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