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Education: A formal Engineering degree in Chemical, Industrial, Mechanical or a B.Sc. in the life Sciences from a known academic institution; A CQE certification and or significant practical experience in the medical device arena are advantageous.
Experience: Minimum three years in the areas of validation and quality engineering in the medical device or pharmaceutical industry.
Languages: Hebrew- speaking, reading, and writing - at a mother tongue level.
English- speaking, reading, and writing - fluent.
• Implementation of policies and procedures to ensure that Quality System Regulations (e.g.: FDA Part 820 Quality System Regulation, ISO 13485 Quality Standard)
• Develop, modify, apply and maintain quality procedures, work instructions and protocols
• Conduct investigations and lead corrective/preventive action planning and problem solving efforts
• Conduct material, component, and equipment qualifications
• Conduct internal audits
• Provide input to engineering, production, and materials to ensure compliance with procedure, regulations, and standards
• Utilize statistical analysis and recognized quality tools (FMEA, risk analysis, hypothesis testing, and root cause analysis)
• Lead as the QA/Compliance responsible through the different project phases
• Evaluate and approve the qualification documentation, i.e. URS, GxP-Risk Assessment, Validation plan, IQ, OQ, PQ and Validation report