HEAD OF QUALITY MANAGEMENT SYSTEM (F/M/D)

About the Position

We are MIETHKE, a globally active, medium-sized medical technology company based in Potsdam. As a technology leader in the field of neurosurgical implants, we develop and manufacture highly specialized solutions for the drainage of cerebrospinal fluid - with precision, innovative strength and responsibility for our patients suffering from hydrocephalus. Our particularly high level of vertical integration is a key success factor.

For our Quality Management department, we are seeking an entrepreneurial leader who can constructively challenge the status quo, inspire people to embrace change and lead them on this journey.

This role offers you the opportunity to play an active part in shaping the future of an internationally active medical device manufacturer. You will take charge of our Quality Management System, play a key role in shaping its further development, and directly apply your experience from international audits and transformation projects to drive sustainable improvements. With the prospect of taking on the role of Quality Management Representative (QMR) and Head of Quality Management, you will in future assume even greater responsibility for the further development of our company’s Quality Management System.

And: diversity, appreciation and tolerance are part of our culture - we would be delighted if this also corresponds to your core values.

Responsibilities

• Lead our Quality Management System (QMS) department, which is currently being restructured, and play an active role in shaping the further development of lean, digital processes and an internationally scalable management system.
• Assume overall responsibility for international regulatory inspections and certification audits (e.g. NMPA, FDA, MDSAP, Notified Bodies) and lead complex audit programs (both internal and external) with a high degree of professionalism and confidence.
• Lead the further development of our quality management system, drive forward eQMS and digitalization initiatives, and create sustainable transparency through meaningful key performance indicators.
• Promptly translate international regulatory requirements into effective processes and standards, and prepare decisions for changes throughout the entire product life cycle.
• Develop your team, foster cross-functional collaboration and create an atmosphere in which quality, personal responsibility and continuous improvement are the norm.
• As the deputy to our Quality Management Representative (QMR), confidently advise the management board and senior executives on regulatory issues within a strategic context.
• Gradually take on more responsibility with the clear prospect of assuming the role of QMR and heading the Quality Management department.

Requirements

• Several years’ management experience in quality management within a regulated environment, ideally in the field of active or implantable medical devices.
• In-depth knowledge of relevant regulatory requirements such as ISO 13485, the EU MDR and, ideally, FDA QMSR, MDSAP, NMPA or comparable international regulatory requirements.
• Successfully led complex audits or regulatory inspections and remain confident, professional and solution-oriented even under pressure.
• Several years’ experience in the further development of QMS structures, as well as in transformation, reorganisation or digitalization projects.
• Entrepreneurial thinking, clear decision-making and the ability to inspire people to embrace change and work towards shared goals.
• Fluency in German and English and confidence in interactions with internal and external stakeholders, as well as during international audits.

We Offer

• Flexible and family-friendly working time arrangements, as well as a working environment that promotes personal responsibility, trust and a healthy work-life balance, and in which we can be ourselves.
• The opportunity to play an active role in shaping the future of our quality management and to take on responsibility in a strategically important role.
• Extensive opportunities for professional and personal development, as well as an open corporate culture with dedicated teams and a high degree of autonomy.
• Sports activities and regular team and company events, as well as other attractive benefits.

About the Company

MIETHKE is a globally active, medium-sized medical technology company based in Potsdam. As a technology leader in the field of neurosurgical implants, we develop and manufacture highly specialized solutions for the drainage of cerebrospinal fluid - with precision, innovative strength and responsibility for our patients suffering from hydrocephalus. Our particularly high level of vertical integration is a key success factor.

Diversity, appreciation and tolerance are part of our culture - we would be delighted if this also corresponds to your core values.

Interested?

If you would like to support us with your experience, commitment and heart, we look forward to receiving your application. Please apply via the “Apply now!” button and not via e-mail.

By the way, we believe that anyone can learn anything. Therefore, please feel free to apply to us if the advertised profile does not seem to suit you completely. We take a close look at every application and are open and curious - even or especially in the case of unusual backgrounds.

If you have any questions about this position, please contact us: +49 331 620 83 4484 or [email protected].

Note on our application and selection process:

We highly value diversity. It is therefore a matter of course for us to consider all applications regardless of age, origin, gender, sexual identity, disability or religious affiliation.