process validation EngineerTalent Search Pte Ltd

European Medical Device company
Responsible for assembly processes for medical devices manufacturing lines
Develop and create documents such as work instruction, assembly procedures and packing instructions
Train, enhance and sustain knowledge of production leaders and operators / technicians
Drive for continuous improvement and monitor for overall product assembly and sub-group operations
Sustain and improve manufacturing process such as BOM, equipment procedures and work instructuons, work station layout and line balancing
Involve in engineering change note and material review board activities
Work on product transfer, process validation till sustaining mass production phases
Update record of materials issues in SAP, including documentation of specification and processes of product transfer
Analyze statistical data and product specifications to ascertain standards and set quality objectives
Requirement
Degree in Engineering
3 years of work experience in process validation of manufacturing assembly process preferably for medical device industry
Knowledge of installation qualification, operational qualification and performance qualification
Experience handling product transfer, cross functional team management
Knowledge with analytical tools such as DOE, FMEA, SPC application
Proven to manage project management and work with cross functional team
Knowledge of lean concepts, Six sigma methodology
Familiar with ISO13485 and GMP
Able to use SAP, MES and Excel
Independent, analytical, multi-task and good organizational skill