Quality Manager (m/f/d)

Quality Manager (m/f/d)

ISO 9001, ISO 14155 and MDR

Location: Remote work throughout Germany

Start date: Flexible – we are happy to accommodate your availability

Working hours: Full-time or part-time (min. 30 hours/week)

For more than 15 years, targomed in Bruchsal has stood for expertise, reliability and commitment – as a trusted partner for clinical trials and medical writing in ophthalmology.

Think quality, take ownership and drive topics forward independently

You are familiar with quality management not only in theory, but have already gained hands-on experience working with a QMS according to ISO 9001? You proactively identify where action is needed, propose solutions and independently follow topics through to completion?

Then you could be a great fit for us.

For our Quality Management team, we are looking for an experienced professional who works in a structured and pragmatic way and takes ownership of their responsibilities. You will work closely with our management and teams while having the freedom to further develop existing processes and contribute your own ideas.

What you can expect

Take ownership of our QMS development – You will manage and further develop our existing quality management system and ensure that requirements are effectively implemented in day-to-day operations.

Help shape digital Quality Management – You will actively contribute to the further digitalization of our quality management system and help transfer existing processes into a suitable digital environment.

Identify and drive topics forward – You will independently identify areas requiring action, set priorities, propose solutions and reliably follow agreed measures through to completion.

Stay audit-ready – You will coordinate the preparation of external ISO 9001 audits or customer audits according to ISO 14155, support the audit process and ensure structured follow-up. You will independently plan and conduct internal audits.

Design pragmatic SOPs & processes – You will create and revise SOPs and QM documents, ensuring that our processes not only meet regulatory requirements but also work effectively in day-to-day operations.

Keep track of CAPAs, deviations & changes – You will coordinate quality-related measures, monitor deadlines and ensure clear and traceable documentation.

Evaluate suppliers and service providers – You will contribute to the qualification and evaluation of our external partners and service providers.

Implement quality requirements – You will support the implementation of relevant regulatory requirements, particularly in connection with ISO 9001, ISO 14155 and the MDR.

Be the point of contact for quality – You will advise management and our teams on quality-related matters and communicate your professional assessment clearly and transparently.

What you should bring

Several years of hands-on experience in quality management

Sound practical knowledge of ISO 9001 and experience working with an ISO 9001-compliant quality management system – this is a mandatory requirement for the position

Experience in preparing for and supporting external audits as well as independently conducting internal audits

Practical experience with SOPs and typical QM processes such as CAPAs, deviations and change control

Knowledge of regulatory requirements under the MDR (EU 2017/745) is an advantage

Knowledge of ISO 14155 is a plus, but not a requirement

A highly independent, structured and proactive way of working – you identify where action is needed and do n