Ondal Medical Systems GmbH | Germany | 36xxx Hünfeld | Permanent position | Full time | Published since: 05.05.2026 on stepstone.de
Validation Engineer (m/f/d)
Ondal Medical Systems GmbH is the world market leader in the production of carrier systems in the field of medical technology. As an integral part of the global medical industry, the quality of our products and the implementation of all specific customer requirements are our most important asset. Become part of a promising company with over 75 years of experience. .
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Your tasks • Your profile • What we offer
Conducting and performing product, software and process validations in compliance with international requirements and standards such as ISO 13485 and FDA 21CFR Part 820 Development and implementation of validation strategies Creating validation documents and qualification protocols Implementation of revalidations Create and maintain master validation plans Cooperation with cross-functional teams (engineering, manufacturing, R&D, suppliers) Application of methods for statistical process control and validation tools Support and implementation of validations by suppliers Development, maintenance and archiving of validation protocols, reports and related documents Conducting process risk analyses Further development of the validation process
Complete studies in engineering (machine engineering, process engineering, electrical engineering) or similar fields Multiannual (>3 years) Experience in the field of validation Multiannual (>3 years) Experience Manufacturing Areas Welding, Painting, CNC Machining and Plastic Spraying German according to CEF level: C1 – flowing knowledge; English according to CEF-Level B2.1 – Advanced knowledge Advanced knowledge in SAP and MS Office Knowledge of the relevant regulatory requirements of ISO 13485 and FDA 21CFR Part 820 for validation
Job at a world market leader in medical technology Crisis-proof workplace in a growing market segment Space and support for (further)development of your own profile Occupational retirement and/or occupational disability provision Above-average remuneration Cheap transport connection (public transport, A7, B27, A66) Contact person
Location
 | Ondal Medical Systems GmbH | |
| 36088 Hünfeld | ||
| Germany |
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