Quality Engineer at Roche - Focus on people!
Ramin joined Roche Diagnostics as a Quality Assurance Manager in the Quality and Regulatory department in 2017.
What is your exact job title?
I am Design Quality Assurance Manager and basically an interface between individual departments at Roche Diagnostics.
What are your responsibilities as Design Quality Assurance Manager at Roche?
As I said, I am the link between single departments – basically between research and development, project management, production and business. One of my tasks is to accompany the development projects in the area of Workflow & IT in terms of quality. I ensure that internal development processes, as well as all regulatory requirements and standards are adhered to – and support the development teams in precisely these tasks.
What qualifications should new colleagues have?
At Roche Diagnostics, we mainly work in the field of medical technology. Thus it is advantageous to have a university degree in engineering. Preferred in the field of medical technology, as students develop a sense of responsibility for medical devices and patient safety during their studies
Was it always clear to you that you would like to work in the medical technology or health care sector?
Yes, I have always been interested in medical technology and this is exactly what I wanted to study – a combination of medicine and engineering. Thus I oriented myself towards biomedical technology. First I was in Tuttlingen at the University of Applied Sciences and then I graduated with a Master's degree at the University of Stuttgart.
What is special about your career at Roche in medical technology?
First of all, it is a peculiarity that we are given a great deal of trust and encouraged to assume responsibility. In the Quality and Regulatory Department, where I work, we do this every day. We also ensure that safe and efficient medical products are brought to market. However, we are also the ones who internally sensitize colleagues from other departments to work and adhere to regulatory requirements and standards.
As a key stakeholder I am responsible for the success of development projects.
In your area you have many rules and guidelines to follow. Is that limiting your autonomous action?
The regulations and standards claim basically a process-oriented approach – From the initial conception to final decommissioning and disposal of medical devices. The regulatory authorities describe and accompany development processes as well as process design. They provide our framework and draw the lines within which we can act. They furthermore serve to ensure the safety and performance of the products on the market!
There are no limits to our creativity – a central pillar of our development – and we are not restricted in this area.
To what extent do you work with other teams and departments?
As I am mainly involved in development projects, I am in daily contact with teams from different departments. We are in constant communication with each other.
Roche's development processes are very precisely defined and always comply with the requirements and standards of the responsible regulatory authority like the Directive 98 / 79/ EC on in-vitro diagnostic of the European Union. My task is mainly to check and monitor the implementation of the internal development processes, regulatory requirements and standards in each development project. Of particular importance is to ensure the visibility of a golden thread in the technical documentation.
How do you feel about the team spirit at Roche?
The self-motivation of each team member is always given! Personally I try to act as a role-model and set a positive example. Especially regarding our processes within the quality management system. Teamwork is always required for product development. We support each other and provide regular input, which is particularly relevant for technical documentation. I then manage the individual areas and departments and consult with the responsible project managers.
What makes Roche so interesting for you as an employer?
For me, Roche is a unique and truly interesting company. We develop diagnostic products, but we are also responsible for treatments and treatment monitoring. At Roche Diagnostics, we work hand in hand with Roche Pharmaceuticals, combining and bringing together both divisions. I don't think there is anything else like that in the healthcare industry. This is what makes working at Roche so exciting and fascinating at the same time.
How important is work-life balance for you?
This is very important to me. But work-life balance also plays a major role for the company. Roche is very open and generous when it comes to working hours or even the place of work. I can arrange my working hours flexibly and actually work from any location – from Waiblingen, Mannheim or our locations in Switzerland. Working from home is also supported and facilitated by Roche. So there is a work-life balance.
If you had to describe Roche in three words, what would that be?
Focus on people!