Jobs for Professionals

(m/f/d)

Ref.No.: 2024-001

Your future role:

As our ISO 13485 Quality Management Representative, you will play a critical role in ensuring compliance with quality management standards for both our company and our medical devices. You will oversee the development, implementation and maintenance of our quality management system and ensure compliance with the regulatory requirements.
Additionally, you serve as the main liaison between our organization and notofied bodies and are the primary contact for your team members regarding our eQMS and associated tasks and processes.

Your key responsibilities include:

• Maintaining and further developing our quality management system in accordance with DIN EN ISO 13485, including
  • Documentation management:
    You are responsible for monitoring and maintaining our quality management system in accordance with legal requirements. We use an electronic QMS based on Atlassian Software (Confluence and Jira).
  • Auditing:
    By planning and conducting internal and external audits as well as customer and supplier audits, you ensure compliance with quality guidelines and identify process improvements to minimize risks in cooperation with external consultants and local authorities
  • Training courses:
    In order to raise awareness of quality standards, you will conduct training courses for employees in quality management and are the first point of contact for QM issues.
• Ensuring that our medical devices comply with regulatory requirements throughout their lifecycle. This includes supporting product development, manufacturing, and post-market surveillance to ensure safety and effectiveness, including
  • Error detection and correction:
    Initiating corrective and preventive measures to continuously improve the quality management system and products
  • Risk Management:
    Identifying, assessing, and mitigating risks within our company to minimize potential negative impacts on operations, products, or objectives.
• As our person responsible for regulatory compliance (PRRC) you are responsible for ensuring that:
  • The conformity of our devices is appropriately checked, in accordance with our quality management system
  • The technical documentation and the EU declaration of conformity are created and kept up-to-date
  • The post-market surveillance obligations are complied with in accordance with Article 10(10) [Article 10(9) of the IVDR].
  • The reporting obligations referred to in Articles 82 to 86 are fulfilled.
  • In the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.

Your ideal qualifications:

• Successfully completed studies in the field of natural sciences, computer science, engineering or similar.
• Professional experience in a regulated environment (e.g. medical technology,) is an advantage, ideally in the quality sector.
• Extensive knowledge of ISO 13485 and MDR regulatory standards.
• Knowledge of the relevant quality standards and technical norms.
• Professional experience in quality management and auditing in a medical device environment.
• Very good verbal and written communication skills in English and German
• IT user skills (Word, Excel, Outlook) with experience in using electronic document management software as an advantage
• A high degree of teamwork and communication skills
• Independent, structured and results-orientated working style

Who we are and what you can expect:

We are a growing company that offers novel molecular diagnostic solutions and intends to make the fastest quality diagnostics accessible to anyone, anywhere, to provide the right treatment at the right time.

We are a family-run business and believe that our team is the key to success.

When joining FRIZ you can expect:

• Flexible working hours
• Home Office possibilities
• Permanent employment
• Attractive salary
• Various further education possibilities