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 an immediate or agreed start date for a

Risk Manager (100%) m/f/d

Do you identify risks before they become a problem? Then you are exactly right with us. Robust risk management 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 support 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 accompany 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 with a first-name 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 getting to know you.