Risk Manager

A.M.I. GmbH; Österreich; Vor Ort; EUR 55.000 - 75.000; Vollzeit

Benefits dieser Stelle

Company cafeteria

Free parking

Zusammenfassung

A.M.I. GmbH, located in Feldkirch, Austria, is seeking a motivated Risk Manager to enhance our risk management system. You will develop and operate the system, facilitate FMEA sessions, and ensure compliance with industry standards.

The ideal candidate has a technical education, is familiar with ISO standards, and is fluent in English. Enjoy a casual atmosphere and the opportunity to work closely with various departments.

Qualifikationen

• You must have a technical education combined with training in risk management.
• Familiarity with ISO 14971, MDR, ISO 13485, and FDA 21 CFR 820 is required.
• Analytical skills and the ability to work independently are essential.

Aufgaben

• Operate and develop the risk management system.
• Facilitate FMEA sessions and risk analyses in interdisciplinary teams.
• Maintain specifications and keep the risk management system up to date.

Kenntnisse

Risk management

FMEA facilitation

Analytical thinking

Fluent English

Ausbildung

Technical education (technical college, apprenticeship, or similar) with additional training in risk management

Tools

ISO 14971

ISO 13485

FDA 21 CFR 820

Jobbeschreibung

With innovative products for coloproctology, urology and urogynecology, we improve medical care worldwide. To strengthen our team at the A.M.I. headquarters in Feldkirch, we are looking for a motivated personality as Risk Manager.

• You will operate and develop our risk management system
• You will facilitate FMEA sessions and risk analyses in interdisciplinary teams
• You will be responsible for risk management plans, reports, and risk-benefit assessments
• You will maintain the specifications and keep the system up to date
• You will train the business departments and report directly to senior management

What you bring to the table

• Technical education (technical college, apprenticeship, or similar) + additional training in risk management
• You are familiar with ISO 14971; you are familiar with MDR, ISO 13485, and FDA 21 CFR 820
• You enjoy facilitating FMEA sessions and risk analyses
• You are fluent in spoken and written English
• You think analytically and can work independently
• Roles with a high degree of autonomy
• Opportunities to work closely with and gain insight into many departments
• Work in a small team with a casual, informal atmosphere and flat hierarchies
• Company cafeteria and free parking