Senior Quality Manager (m/f/d) Sonovum GmbH

Wandelbots GmbH; Leipzig; Hybrid; EUR 95.000 - 125.000; Teilzeit

Benefits dieser Stelle

Childcare allowance

JobBike

Zusammenfassung

Sonovum is seeking a Senior Quality Manager to maintain and evolve a process-oriented quality management system. You will align regulatory requirements with product development, including software and ML components, ensuring auditability and sustainable quality.

You will collaborate with Engineering, Clinical Affairs, and Operations to drive pragmatic quality solutions while maintaining compliance with MDR, ISO standards, and FDA QMSR. Flexible, cross-functional team culture is offered.

Qualifikationen

• Bachelor’s or master’s degree in medical technology, engineering, life sciences, or a related field.
• At least 5 years of experience in quality management for active medical devices, ideally with a software component.
• In-depth knowledge of the MDR, ISO 13485, ISO 14971, and FDA QMSR (21 CFR Part 820).
• Experience conducting and supporting audits, as well as dealing with Notified Bodies and regulatory authorities.
• Experience with active medical devices and/or software-based or machine learning–supported systems is a plus.
• A structured, precise, and independent work style combined with a strong commitment to quality.
• Clear and persuasive communication in German and English, as well as the ability to proactively drive initiatives forward.

Aufgaben

• Maintain and further develop our QMS
• Ensure that processes are implemented, understood, and followed throughout the entire product lifecycle—particularly in the context of software and machine learning components
• Develop pragmatic and actionable quality solutions that enable innovation while ensuring regulatory compliance
• Responsible for audits, inspections, NCP, and CAPA
• Perform PMS activities
• Take on key risk management responsibilities
• Work closely and collaboratively with Engineering, Clinical Affairs, and Operations

Kenntnisse

Communication in German & English

Structured, precise, independent work

Strong commitment to quality

Team collaboration across disciplines

Regulatory initiative driving

Ausbildung

Bachelor’s or Master’s in medical tech, engineering, life sciences

Jobbeschreibung

About Sonovum

At Sonovum, you’ll work with an interdisciplinary team that values curiosity, collaboration and ownership — and you’ll contribute to a technology with real clinical impact.

If you’re driven by purpose and excited to grow with a company on the rise, we would love to hear from you.

This position is also available on a part-time basis (approx. 50%) | Flexible work arrangements

Your Roll

As a Senior Quality Manager, you will play a central role in maintaining and further developing our process-oriented quality management system and the KPIs derived from it.
In doing so, you will ensure that standard-compliant policy documents are created and refined in a way that is both pragmatic and scalable.
In this role, quality is understood as an integral part of product development—with the goal of integrating regulatory requirements into technical and clinical processes early on and in a meaningful way. Working closely with interdisciplinary teams, you will make a significant contribution to the auditability and sustainable quality of our products.

Your tasks:

• Maintain and further develop our QMS


• Ensure that processes are implemented, understood, and followed throughout the entire product lifecycle—particularly in the context of software and machine learning components


• Develop pragmatic and actionable quality solutions that enable innovation while ensuring regulatory compliance


• Responsible for audits, inspections, NCP, and CAPA


• Perform PMS activities


• Take on key risk management responsibilities


• Work closely and collaboratively with Engineering, Clinical Affairs, and Operations

What you bring to the table

• Bachelor’s or master’s degree in medical technology, engineering, life sciences, or a related field


• At least 5 years of experience in quality management for active medical devices, ideally with a software component


• In-depth knowledge of the MDR, ISO 13485, ISO 14971, and FDA QMSR (21 CFR Part 820)


• Experience conducting and supporting audits, as well as dealing with Notified Bodies and regulatory authorities


• Experience with active medical devices and/or software-based or machine learning-supported systems is a plus


• A structured, precise, and independent work style combined with a strong commitment to quality


• Clear and persuasive communication in German and English, as well as the ability to proactively drive initiatives forward

What We Offer

• A key role with significant responsibility at an innovative medtech company


• The opportunity to actively help shape the regulatory framework for an innovative, machine-learning-based medical device.


• A collaborative, mission-driven work environment with short decision-making paths.


• Opportunities for professional development and ongoing training.


• Flexible work models and a modern work environment.


• Attractive compensation package, including a childcare allowance and JobBike.


• A corporate culture that values initiative, a sense of responsibility, integrity, and team spirit.