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Medical Validation Engineer with FDA/FMEA/ISO @ Austin, TX

Company: Radiansys, Inc.
Location: Austin
Posted on: May 21, 2020

Job Description:

Please find an urgent requirement for Fulltime. Please respond ASAP with your profile vikashradiansys.com mailtovikashradiansys.com Role Medical Validation Engineer with FDAFMEAISO Location Austin, TX Onsite Duration Fulltime role Overview FDA inspection experience as SME interface. bull Develop and track validation related metrics. (e.g. Validation Master Plan) bull Provide validation training and consultation services on validation policies and practices. bull Work closely with engineering and quality personnel providing expertise and guidance for verifying and validating new products and processes. bull Provide guidance on defining the validation verification strategy, including risk management mitigations, verification and validation plans, protocols, and reports. bull Provide risk management training and facilitation for FMEA and control plan development sessions. bull Review, analyze and provide recommendations for verification and validation test data. bull Provide guidance on resolving deviations and ECO associated with verification and validation activities. bull Evaluate validation reports to ensure compliance with ISO and FDA regulation requirements. bull Provide ISO 13485 and FDA regulation guidance (specifically CFR 820). bull Verify the validation activities as a dedicated subject matter expert to ensure the validation processes fully comply with ISO and FDA regulations requirements. Primary Skills Knowledgeable in statistical rationale and sampling plans. bull Experience creating verification and validation strategy, plans, protocols, and reports. bull Experience with Project Managing Process Validation in a Medical Environment. ( Execution Master Validation Plans for a Medical program) bull Understanding of the operations and validation of facilities and utilities bull Familiarity with PCBA and sub-assembly production processes. bull Familiarity with automated assembly and manual processes bull Strong SPC skills, control plan and FMEA experience. bull Good knowledge of quality and process control systems. bull Experience and working knowledge with ISO13485 and or FDA regulations. Secondary Skills Six-Sigma, Lean, MiniTab Educational Qualifications B.S Degree in Technical or Engineering Practice Best, Vikash Kumar 510.790.2000 Ext 1009 RADIANSYS INC

Keywords: Radiansys, Inc., Austin , Medical Validation Engineer with FDA/FMEA/ISO @ Austin, TX, Healthcare , Austin, Texas

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