Minimum requirement for performance of these duties is a bachelor’s degree in Biomedical, Mechanical Engineering, or a closely related field.
Responsible for initiating, implementing and completing change control, deviations, investigations, impact/risk assessments, root cause analysis, and CAPAs
Developing risk assessments, reductions, controls, and monitoring which will be transferred as part of the design output to ensure risk management throughout the life of the device and manufacturing process.
Validation engineer performs Process capability analysis to ensure that the manufacturing process at the supplier site can produce parts within specifications.
Develop, manage and review PFMEA(s), Risk Management Plans, and/or Risk Management Reports
Technical documentation for the verification and validation strategy drafted in compliance with company current regulatory standards by using appropriate company templates.
Organize and manage the daily operations of the validation group and assure that master plans, protocols and reports are generated and approved within predetermined timelines.
Ensure strict compliance with standards and templates in relation to the writing of Technical Documentation
Involve in preparing and reviewing the Validation Master Plan and implement it in accordance with FDA regulations.
Interact with Cross functional teams to review Customer/User requirements/ Function Specifications based on flow diagrams and business requirements.
Review and approve product complaints, change controls related to the product
specifications and deviations
Train and assist personnel involved during the project and coordinated with contract location to ensure the safe transfer of parts.
Outline plan to verify device product design (DVT) including the proposed reliability and safety tests.
Conduct meetings with R&D and Sterilization SME to discuss adoption at the Supplier site, qualification procedures, tests needed for the supplier.
Manage/Review DFMEA, PFMEA and assist Suppliers in developing manufacturing/test methods and validate components/assemblies.
Perform gap analysis of current standard operating procedures (SOPs) against industry and regulatory standards to identify missing SOPs and quality control documentation
Define Validation approach, develop protocols (IQ/OQ/PQ & TMV) and assist in validation executions as required.