Du leitest globale R&D-Projekte im Qualitätsmanagement und treibst Risikomanagement sowie die Überwachung von CAPA und Nichtkonformitäten voran.
Anforderungen
- •BSc/MSc in a relevant field
- •Mindestens 5 Jahre Erfahrung
- •Understanding of regulatory standards
- •Knowledge of quality management systems
- •Passion for quality management
- •Strong communication skills
- •Self-driven and collaborative
- •Adaptability to dynamic environments
Deine Aufgaben
- •Leiten von globalen R&D-Projektaktivitäten als Qualitätsmanagement-Leiter.
- •Durchführen von Risikomanagementaktivitäten für R&D-Projekte.
- •Fungieren als Experten für grundlegende Sicherheits- und Leistungsanforderungen.
- •Bearbeiten und Überwachen von CAPA, Nichtkonformitäten und geplanten Abweichungen.
- •Vertreten von Ambu während Benannten Stellen-Audits und regulatorischen Inspektionen.
Deine Vorteile
Great opportunities for development.
Wide range of employee benefits.
Original Beschreibung
**Senior Quality Management R&D Specialist**
Are you driven by a passion for quality? Do you bring a wealth of experience in Quality Management for Medical Device development, particularly in Medical Electrical Equipment? Are you eager to lead compliance, foster continuous improvement, and contribute to groundbreaking global R&D projects?
Your next career step could be as a **Senior QM R&D Specialist** at Ambu.
**Why Ambu?**
At Ambu, we are pioneers in the medical device industry, committed to advancing patient care worldwide. As a Senior QM R&D Specialist, you will play a vital role in expanding our **Global Quality Management R&D team**, embedded in a culture of collaboration, integrity, and innovation.
You'll join a growing team of 16 quality engineers located in **Ballerup, Denmark**, and **Augsburg, Germany**.
This role offers the flexibility to be based in either **Ballerup** or **Augsburg**.
**Key responsibilities**
As Senior QM R&D 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.
In this position, you’ll enjoy a dynamic work environment where your impact extends across projects and processes. Your main responsibilities will include:
* Leading global R&D project activities as the **Quality Management Lead**.
* Driving **Risk Management** activities for R&D projects.
* Acting as the **go-to expert** for basic safety and essential performance requirements.
* Handling and monitoring **CAPA**, **non-conformities**, and **planned deviations**.
* Representing Ambu during **Notified Body audits** and regulatory inspections.
**Suggested candidate profile**
Skills can be earned in different ways, however, we imagine your background entails:
* A BSc/MSc in a relevant field is required, along with at least **five years of experience** in a highly regulated industry.
* You bring a **deep understanding** of the regulatory and quality standards governing **medical devices** or **pharma**, including **risk management**, **quality management systems**, and **safety requirements** (such as ISO 14971, ISO 13485, EU MDR, MDSAP, and UK MD).
* A **passion for quality** and a focus on **QM business partnering** with the organization are essential.
* As a person, you are **outgoing**, have a strong **business understanding**, and excel in **communicating quality requirements** while facilitating **effective implementation** within a global organization.
* Being **self-driven** and comfortable taking the lead, you also value **collaboration**, are **open-minded**, and adapt well to **dynamic and fast-paced environments**.
**Ambu – a visionary and international workplace where your efforts matter**