Risk Manager

About the job

About Brütsch Technology AG

We are a family business founded 55 years ago, developing and producing sophisticated solutions for medical technology and industrial automation as a private label and OEM partner. Our headquarters with nearly 160 employees is located in Beringen (SH).

To strengthen our QMR team, we are looking for a

Risk Manager (100%) m/f/d

Do you identify risks before they become a problem? Then you are exactly right with us. A robust risk management system is the backbone of our product safety. Without you, safety remains a matter of chance. You ensure that risks are systematically identified, assessed, and minimised – from development to market surveillance of our products. This is not dry paperwork but a responsible role in a modern MedTech company where your commitment makes a daily difference in the lives of patients.

Your tasks

• You are responsible for establishing, implementing, and further developing the risk management system according to ISO 14971 throughout the entire product lifecycle.
• You moderate risk analyses (including FMEA) together with development, production, and Regulatory Affairs and ensure the quality of risk files.
• You create and maintain compliant risk management files and integrate these with post-market surveillance and vigilance data.
• You evaluate complaints, CAPAs, and market experiences, identify risk trends early, and derive effective measures.
• You accompany audits and regulatory inspections as the risk management expert.
• You train colleagues in risk management methodology and promote a risk culture that is lived daily – not just documented.
• You support the design, execution, and documentation of design, process, and test method validations.

Your profile

• Several years of experience in risk or quality management in the MedTech industry.
• Sound knowledge of ISO 14971 and ISO 13485 as well as experience with FMEA methodology and validations.
• Analytical, structured working style combined with the ability to communicate complex matters clearly.
• Strong communication skills in fluent German and English.

Our offer

• Short decision-making paths, lots of responsibility, and room for your ideas.
• A motivated team eager for innovation.
• A respectful, equal-footing working environment and informal culture.
• A modern working environment and attractive employment conditions.
• Development prospects and long-term security.

Ready to make a difference with us?

We look forward to meeting you.