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

Christoph Miethke GmbH & Co. KG; Potsdam; Hybrid; EUR 110.000 - 150.000; Vollzeit

Benefits dieser Stelle

Flexible hours

Professional development

Open corporate culture

Team events

Zusammenfassung

Christoph Miethke GmbH & Co. KG in Potsdam seeks a leader to take charge of the Quality Management System (QMS) and eventual role as QMR. You will shape lean, digital processes and an internationally scalable management system, and drive ongoing regulatory improvements.

You will supervise international inspections, advance eQMS solutions, and guide the team through transformation and regulatory changes, with a focus on quality and continuous improvement.

Qualifikationen

• Several years of management experience in quality management within a regulated environment.
• In-depth knowledge of ISO 13485, EU MDR, FDA QMSR, MDSAP, NMPA or similar regulations.
• Experience leading complex audits or inspections and working under pressure.
• Experience developing QMS structures and leading transformation/digitalisation projects.
• Entrepreneurial thinking, decisive leadership, and change management ability.
• Fluency in German and English with strong stakeholder interaction.

Aufgaben

• Lead the Quality Management System (QMS) department, drive lean and digital processes, and scalable management systems.
• Oversee international regulatory inspections and certification audits (e.g., NMPA, FDA, MDSAP).
• Drive eQMS development and digitalisation initiatives with meaningful KPIs.
• Translate international regulatory requirements into processes and standards across the product life cycle.
• Develop the team and foster cross-functional collaboration for continuous improvement.

Kenntnisse

Quality management leadership

Regulatory audits experience

Change and transformation leadership

Regulated environment experience

German and English fluency

Tools

eQMS

Digitalisation tools

Jobbeschreibung

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.

YOUR TASKS

• You will 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.
• You will assume overall responsibility for international regulatory inspections and certification audits (e.g. NMPA, FDA, MDSAP, Notified Bodies) and lead complex audit programmes (both internal and external) with a high degree of professionalism and confidence.
• You will lead the further development of our quality management system, drive forward eQMS and digitalisation initiatives, and create sustainable transparency through meaningful key performance indicators.
• You will promptly translate international regulatory requirements into effective processes and standards, and prepare decisions for changes throughout the entire product life cycle.
• You will 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), you will confidently advise the management board and senior executives on regulatory issues within a strategic context.
• You will gradually take on more responsibility with the clear prospect of assuming the role of QMR and heading the Quality Management department.

YOUR PROFILE

• You have several years’ management experience in quality management within a regulated environment, ideally in the field of active or implantable medical devices.
• You have 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.
• You have successfully led complex audits or regulatory inspections and remain confident, professional and solution-oriented even under pressure.
• You have several years’ experience in the further development of QMS structures, as well as in transformation, reorganisation or digitalisation projects.
• You think entrepreneurially, make clear decisions and inspire people to embrace change and work towards shared goals.
• You are fluent in German and English and are confident in your interactions with internal and external stakeholders, as well as during international audits.

OUR 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.

If you have any questions about this position, please contact us: [phone] or [e-mail].

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.