Job Description
Job Description
Conduct IQ/OQ/PQ validation of machinery to enhance quality control and ensure regulatory compliance; Develop assembly procedures and review mechanical manufacturing processes to meet quality assurance standards and ensure dimensional accuracy of medical devices; Perform product evaluation using Advanced CAD/CAM, SolidWorks, and statistical analysis.
Conduct Finite Element Analysis (FEA) using 2D/3D simulations to assess mechanical performance and stress tolerances; Define critical, major, and minor characteristics for assemblies and parts to ensure compliance with quality assurance provisions; Conduct internal audits and develop technical guidelines to meet ISO Standards and support annual audits; Evaluate non-conforming parts for compliance with engineering standards and determine whether modification or rejection is necessary; Develop and implement quality assurance programs including engineering materials performance.
Conduct CAPA investigations and collaborate with cross-functional teams to enhance product quality and process reliability, applying principles of Kinematics and dynamics of machinery; Monitor gauge calibration and creation, ensuring measurement precision and adherence to GD&T standards; Establish calibration procedures for inspection instruments.
Requirements
Must have a Bachelor's Degree in Mechanical Engineering or Biomedical Engineering plus skills and knowledge of Advanced CAD/CAM, Solidworks, Material Performance, FEA, Statistical Analysis, Kinematics and dynamics of machinery, mechanical manufacturing processes.
**Submit résumé referencing job code HAL003 to HR**
