Risk Manager (100%)

Automation, Medical technology

Beringen

Full-time

Immediately

Do you identify risks before they become a problem? Then you’ve come to the right place. Robust risk management is the backbone of our product safety. Without you, safety is left to chance. You ensure that risks are systematically identified, assessed, and minimized—from product development through market surveillance. You won’t be doing dry paperwork here, but rather taking on a responsible role in a modern company where your efforts make a difference every day.

Job description

Your tasks and responsibilities

You are responsible for establishing, implementing, and further developing the risk management system in accordance with ISO 14971 throughout the entire product life cycle.
They facilitate risk analyses (including FMEA) in collaboration with the development, production, and regulatory affairs teams and ensure the quality of the risk documentation.
You create and maintain risk management files that comply with regulations and integrate them with post-market surveillance and vigilance data.
They analyze complaints, CAPAs, and market feedback, identify risk trends early on, and develop effective measures.
You will assist with audits and regulatory inspections in your capacity as a risk management specialist.
They train their colleagues in risk management methodologies and foster a risk culture that is put into practice in everyday work—not just documented.
You will assist with the planning, implementation, and documentation of design, process, and test method validations.

Your profile

Several years of experience in risk or quality management in the medtech industry.
In-depth knowledge of ISO 14971 and ISO 13485, as well as experience with the FMEA methodology and validations.
An analytical, structured approach to work, combined with the ability to explain complex issues in a way that is easy to understand.
Excellent communication skills; fluent in German and English.

What we offer

Quick decision-making processes, a lot of responsibility, and room for your ideas.
A motivated team that’s eager to innovate.
A respectful, collaborative environment where everyone is treated as equals and where people address each other informally.
A modern work environment and attractive employment terms.
Development prospects and long-term security.

About Brütsch Technology

At Brütsch Technology, we are passionate about developing and producing sophisticated solutions that advance medical technology and industry. Since our foundation in 1971, we have developed from a small business into a leading, globally operating technology company.

150+

4500 m2

Employees

Years of experience

Business areas

Company location Beringen

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