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Head of Quality Management for Medical Device Development (m/f/d)

lammhrFrankfurt, Hessen, Deutschland
On-site Temporary

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Experience Level

Manager

Qualifications

Required Qualifications:PhD in a natural sciences field with 5+ years of experience supporting laboratory functions, particularly quality-related activities, and involvement in reviewing/assessing technical documentation. Experience in leading an operational quality unit, with additional licenses and certifications preferred, along with technical and functional skills. Experience in the pharmaceutical/medical technology industry. Familiarity with managing and conducting audits/inspections (laboratory requirements, ISO 13485, 21 CFR 820) and creating/reviewing approval documents or technical documentation. Fluency in English (negotiation level) and good knowledge of German.

About the job

We are seeking a Head of Quality Management for Medical Device Development for our client, an internationally active, research-oriented company that focuses on high-quality products in aesthetic medicine. This position offers a modern working environment that prioritizes innovation, quality, and the well-being of people.

The primary objective of this role is to ensure that product development is globally compliant with regulatory standards. You will establish harmonized, global processes within the R&D sector. Through systematic monitoring and reporting, you will oversee the quality management system, manage activities, identify deficiencies, and initiate process improvements.

Key Responsibilities:

  • Oversee global laboratory activities for all products.
  • Standardize and harmonize laboratory-related quality processes on a global scale.
  • Create, review, and maintain procedural documents related to laboratory quality activities and standards.
  • Review and approve laboratory quality-related documents; participate in project meetings; coordinate with laboratory operational staff.
  • Manage deviations; track CAPA, OOS, non-conformities/deviations.
  • Conduct internal audits; support external audits/inspections in R&D quality.
  • Facilitate external audits to support supplier qualifications in the laboratory domain.
  • Document and evaluate laboratory-related quality-critical conditions in quality data reporting.

About lammhr

Our client is a prominent player in the aesthetic medicine sector, dedicated to research and innovation, providing high-quality products that enhance the well-being of individuals. Join a team that values quality and continuous improvement in a supportive and forward-thinking environment.

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