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QA Technician Ii
hace 6 meses
**Summary**:
You will visually inspect, measure and perform functional testing on pipette tips, tubes and racks using a variety of equipment.
**General Responsibilities**:
- 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.
**Knowledge, Skills, Abilities**
- Attention to detail.
- Basic knowledge of working in a lab environment
- Ability to work in a fast-paced environment.
- Ability to work both independently and as a team member.
- Ability to function in a multifaceted environment and balance multiple priorities simultaneously.
- Digital literacy with an understanding of Microsoft Excel, use of software systems (Agile, Trackwise, Macola).
- Intermediate math skills
- This position requires flexibility with work hours to meet customer demands and business priorities and objectives.
