Head Quality Management MedTech

G-Metrics GmbH; Hannover; Hybrid; EUR 100.000 - 125.000; Vollzeit

Zusammenfassung

A MedTech and Digital Health company is seeking an experienced Quality Manager. This role involves actively managing the ISO 13485 Quality Management System and ensuring compliance with EU MDR throughout the product lifecycle. Ideal candidates will have 5+ years in MedTech Quality Management, a strong understanding of ISO 13485, and be comfortable with hands-on tasks. This position offers flexible working models and significant impact on product success. Apply with your CV via LinkedIn or directly contact us.

Leistungen

Flexible working models (hybrid/remote by arrangement)

Competitive compensation

Broad technology exposure: implants, wearable, software, AI

Qualifikationen

• 5+ years of hands-on experience in MedTech Quality Management.
• Proven experience with EU MDR implementation.
• Experience with audits and technical documentation.

Aufgaben

• Full responsibility for maintaining and developing the ISO 13485 Quality Management System.
• Ensuring ongoing EU MDR compliance throughout the product lifecycle.
• Preparing, leading, and supporting internal, supplier, and notified body audits.

Kenntnisse

Hands-on mindset

Strong practical knowledge of ISO 13485

Fluent in English

Structured working style

Ausbildung

Degree in Medical Engineering, Engineering or Life Sciences

Jobbeschreibung

ISO 13485 | EU MDR | Implantable Biosensors

G-Metrics GmbH is a MedTech and Digital Health company in ophthalmology. We develop AI‑driven solutions for predictive glaucoma care, spanning implantable biosensors, wearable and software for continuous monitoring.

We are a small, technology‑driven organization in a build‑up phase. Quality Management at G‑Metrics is not a support function, it is a core enabler for product development, regulatory approval, and company growth.

We are looking for an experienced, pragmatic Quality Manager who takes ownership and is comfortable working hands‑on.

Your Role

You will own and actively manage the Quality Management System at G‑Metrics and ensure compliance with ISO 13485 and EU MDR across our product portfolio. This is not a coordination‑only role. It requires experience, judgment, and execution in a dynamic startup environment.

Responsibilities

• Full responsibility for maintaining and developing the ISO 13485 Quality Management System
• Ensuring ongoing EU MDR compliance throughout the product lifecycle
• Preparing, leading, and supporting internal, supplier, and notified body audits
• Creating, maintaining, and approving SOPs, QMS documentation, and technical documentation
• Ownership of risk management activities (ISO 14971), CAPA processes, change and configuration management
• Quality support for product development across implantable medical devices and wearable
• Close collaboration with engineering, regulatory, management, and external partners
• Translating regulatory requirements into practical, scalable processes

Profile

• Degree in Medical Engineering, Engineering, Life Sciences, or a comparable field
• 5+ years of hands‑on experience in MedTech Quality Management
• Strong practical knowledge of ISO 13485
• Proven experience with EU MDR implementation
• Experience with audits and technical documentation
• Ability to work independently and take responsibility
• Hands‑on mindset — willing to create, review, and improve documents yourself
• Structured working style and clear communication
• Fluent in English; German is a plus

Nice to have

• Exposure to implantable devices
• Startup or scale‑up background

What We Offer

• A key role in shaping the quality backbone of a growing MedTech company
• Direct impact on product success, regulatory milestones, and company value
• Broad technology exposure: implants, wearable, software, AI
• Short decision paths and direct access to management
• High level of ownership and responsibility
• Flexible working models (hybrid / remote by arrangement)
• Competitive compensation

Important to Know

This role is not suited for candidates looking for a purely administrative or coordinating position. We are looking for someone who understands regulation, thinks structurally, and executes pragmatically.

Interested?

Please apply with your CV (and optionally a short note) via LinkedIn or contact us directly at:

[e-mail]