QC Technician II

Job Description

Responsibilitites:

• -Conduct visual inspections, dimensional and functional testing for raw material, molded components, pipette tips, tubes, racks etc.
• -Use Agile PLM to read drawings, able to interpret drawing requirements and tolerances
• -Use of calipers, comparator, CMM, gages, centrifuge, manual pipettes, vertex, Keyence etc.
• -Measure the internal and or external diameters of pipette tips and tubes using the CMM (Coordinate Measuring Machine). Export data as text file and then transfer to an excel template. Evaluate results and verify specifications and tolerances on template or form are correct as specified on product drawing or Product Quality Requirements.
• -Document record results and evaluate results and verify specifications and tolerances as specified on product drawing or Product Quality Requirements.
• -Follows applicable procedures, work instructions, CTQ drawings, product quality requirements.
• -Communicate results and notifies to the immediate supervisor of any deviation to the established standards. Use Trackwise System to document Non-Conformances.
• -Execute protocols and test plans in the evaluation of plastic components supporting to Quality Engineers.
• -Support during internal and external audits ISO13485, ISO9001
• Participates on continues improvement activities PPI (Gembas, JDI, Kaizen)
• Other duties may be assigned as required.

Education:

• High school diploma, technical career or equivalent required

Experience

• -1+ years’ experience related to quality control, preferably in a laboratory environment, medical devices industry related to ISO13485, 21 CFR Part 820 (FDA Regulation) desired.
• -Experience measuring parts preferred.

Skills