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Posted 16 hours ago
Validation Engineer
Knightec GroupValideringsingenjör, Medtech
Requirements
Validation experience, Deviation management, Traceability systems, ISO 13485 knowledge, Degree in MedTech, Chemical Engineering, or Biotech, Fluent Swedish and English
Skills
Quality AssuranceISO 13485QMS
About the role
Responsibilities
- Lead and conduct qualification of equipment and systems
- Develop and review quality and regulatory documents within medical technology, pharmaceuticals, or food sectors
- Perform process validation and GAP analyses
- Handle classification and release of medical devices
- Work with MDD/MDR, ISO 13485, Design control, 21 CFR 820, and QMS
Requirements
- Experience in product or process validation
- Experience in deviation management
- Experience with traceability systems
- Knowledge of ISO 13485
- Degree in medical technology, chemical engineering, biotechnology, or equivalent
- Fluency in Swedish and English (written and spoken)
About the Company
Semcon and Knightec have merged to form Knightec Group, Northern Europe's leading strategic partner in product and digital service development. We help customers realize their strategies from idea to finished solution through cross-functional expertise.
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Knightec Group · Göteborg