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(Urgent) ±Û·Î¹ú ü¿ÜÁø´Ü±â¾÷ R&D Verification & Validation Sr.Scientist
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¤ýIndependently design, manage, and conduct verification and validation testing of point of care lateral flow tests.
¤ýMaintains detailed knowledge and understanding of product or process design.
¤ýLead, develop and implement design characterization, DOE¡¯s and design verification strategies for efficient, complete and robust testing through report completion and anomaly resolution.
¤ýAnticipate, recognize and resolve technical issues and avoids reoccurrences.
¤ýUtilizes appropriate experimental, statistical and project management tools.
¤ýRecognizes opportunities and proposes novel ideas for significant operational, process or product improvements.
¤ýProactively identify opportunities for significant operational, process or product improvements.
¤ýLead and support risk management activities, including FMEA¡¯s, to ensure robust and reliable test methods are developed to ensure comprehensive test coverage.
¤ýProvides diverse, independent technical data and insight to support risk management evaluation and assessment.
¤ýEffectively balances compliance risk and business risk to create and review risk management files.
¤ýDemonstrates advanced statistical techniques and or project management tools.
¤ýSupports Design Reviews with a focus on V&V activities, ensuring test data is prepared appropriately and presented with clarity.
¤ýProvides audit inputs and support as required.
¤ýDemonstrates fiscal responsibility through actionable recommendations and accomplishments.
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¤ýMaster's degree in scientific and/or technical field
¤ý4+ years verification experience in medical device development and biologics essential with a strong Molecular and Biochemical background
¤ýStrong experience in device / assay design and characterization, including DOE optimization where appropriate.
¤ýAdvanced skills in statistical analysis.
¤ýExpertise in design and optimization of serological diagnostic tests
¤ýStrong analytical and quantitative skills.
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hubcareer@hotmail.com
010-3235-2771
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