Work Schedule
First Shift (Days)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety StandardsJob Description
Responsibilities
- Conduct visual inspections, dimensional and functional testing for raw materials, molded components, pipette tips, tubes, racks, etc.
- Use Agile PLM to read drawings and interpret drawing requirements and tolerances.
- Operate tools such as calipers, comparators, CMM, gages, centrifuges, manual pipettes, and Keyence equipment.
- Document and evaluate results, verifying specifications and tolerances as specified on product drawings or Product Quality Requirements.
- Follow applicable procedures, work instructions, CTQ drawings, and product quality requirements.
- Communicate results and notify the immediate supervisor of any deviation from established standards. Use the Trackwise System to detail Non-Conformances.
- Complete protocols and test plans for evaluating plastic components to support Quality Engineers.
- Support internal and external audits, including ISO13485 and ISO9001.
- Participate in continuous improvement activities such as PPI (Gembas, JDI, Kaizen).
- Perform other duties as required.
Requirements
- Demonstrated capability to conduct detailed visual inspections and functional testing.
- Proficiency with Agile PLM and the ability to interpret complex drawings.
- Experience using a variety of testing tools and equipment.
- Strong ability to produce detailed and accurate documentation.
- Strong communication abilities to effectively report deviations and results.
- Experience in supporting audit processes, both internal and external.
- A collaborative approach and a dedication to continuous improvement.
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