Senior Quality System Specialist

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 us for a career #ForeverForward! 

A global job with impact 

We are looking for a Senior Quality System Specialist who can take up this exiting position in our Corporate QA Systems department out of HQ in Ballerup, Denmark. You will work within the “QMS & Audit” team with colleagues located both in HQ and our R&D Site in Augsburg, Germany. 

You will be part of a strong quality culture where take charge, team up and stay true are our core values. 

As Senior Quality System Specialist, you will get a varied working day in a dynamic organization where you get to influence Ambu’s 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 QA Systems area of responsibility. 

Experience and passion  

Skills can be earned in different ways, however, we imagine your background entails:

• A relevant academic background, BSc / MSc 

• At least 6-8 years’ experience of working within a quality organization for medical devices or pharmaceuticals. 

• In depth knowledge of relevant regulations for medical devices e.g., ISO13485, EU MDR, MDSAP, UK MD 

• Demonstrated experience of working with QMS improvement activities and performing quality training activities 

• Demonstrated experience as a lead auditor. 

• 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. 

Deadline  

If you are interested in the position, please apply as soon as possible. Note that candidates will be evaluated and invited for interviews on a continuous basis.  

This job ad might be online until February 15, 2024, but once we have found the right candidate, this ad will no longer be online. 

If you have any questions about the position, you can contact Director of Corporate QA Systems, Vibeke Lillie Gadsbøll, at vgad@ambu.com.  

Your application will be treated with confidentiality.