Head Quality Management MedTech

vor 2 Wochen

Hannover, Niedersachsen, Deutschland G-Metrics GmbH Vollzeit

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
s
mall, 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.

Your 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 audits

supplier audits

notified body audits

  • Creating, maintaining, and approving:

SOPs

QMS documentation

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

Your 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:

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