Do you have a true passion for QA business partnering? Do you want to be the corporate process owner of the global QMS processes for Change Control? Are you driven by aligning and setting direction?
Then this might be your defining moment. Apply today and join Ambu for a career #ForeverForward!
A global job with impact
We are looking for a Senior Quality System Specialist who can take up this exciting position in our Global Quality Management, QMS Processes department out of HQ in Ballerup, Denmark. You will work within the QMS Processes team with colleagues located both in HQ and our R&D Site in Augsburg, Germany, but your interface will span across Ambu’s global presence.
You will be part of a strong quality culture where “take charge, team up and stay true” are our core values.
Key responsibilities
As Senior Quality System Specialist, you will get a varied working day in a dynamic organization where you get to influence Ambu’s QMS processes as well as your own daily tasks and responsibilities.
Your key responsibilities will be to:
- Maintain, develop, and improve global QMS processes with a QMS simplicity mindset
- Be the Corporate process owner of the global QMS process for Change Control
- Set direction for and ensure alignment of Change analysts across Ambu sites and establish formal change analyst forum
- Perform various quality training activities
- Support the organization in understanding external QMS process requirements and effectively implementing these
- Act as lead auditor in internal audits and corporate audits of other Ambu sites
- Participate in Notified Body audits and inspections by authorities
- Drive or participate in prioritized business project activities related to QMS Processes area of responsibility
- Act as NCR process expert and CAPA Handler in relation to global QMS Processes owned processes and internal/corporate audit NCRs
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 your background entails:
- Around 10+ years of experience of working within a quality organization for medical devices
- A relevant academic background, BSc / MSc
- In depth knowledge of relevant regulations for medical devices e.g., ISO13485, EU MDR, MDSAP, UK MDR
- Demonstrated experience of working with QMS improvement activities and performing quality training activities in a regulated environment
- Demonstrated experience and certification as a lead auditor within relevant medical device regulation
- Passion for quality and focus on QA business partnering with the organization
As a person, you are outgoing, have a good business understanding and are confident in communicating quality requirements and facilitating effective implementation in an organization.
It is important that you are self-driven, like to take lead, and that you can work independently. You take pride in good collaboration, and you are open-minded and see possibilities even when daily life is dynamic and hectic.
Ambu is a global company and English is our corporate language, which requires that you speak and write English at a relatively high level.
If you have any questions about the position, you can contact Head of QMS Processes, Mette Rittmeyer, at mrit@ambu.com.
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.