Work Schedule

First Shift (Days)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

Responsibilities

Conduct visual inspections, dimensional, and functional testing for raw materials and molded components.Use Agile PLM to read and interpret drawing requirements and tolerances.Operate calipers, optical comparators, CMM, gauges, centrifuges, manual pipettes, Vertex, and Keyence equipment.Measure internal and external diameters of pipette tips and tubes using the CMM. Export data as a text file, transfer to an Excel template, and evaluate results to verify specifications.Document and evaluate results, ensuring specifications and tolerances meet product drawing or Product Quality Requirements.Follow applicable procedures, work instructions, CTQ drawings, and product quality requirements.Communicate results and notify the immediate supervisor of any deviations from established standards using the Trackwise System to record Non-Conformances.Implement protocols and test plans to evaluate plastic components, supporting Quality Engineers.Support internal and external audits, including ISO13485 and ISO9001.Participate in continuous improvement activities such as Gembas, JDI, and Kaizen.Perform other duties as assigned.

Requirements

Confirmed experience in quality control and inspection techniques.Ability to successfully implement protocols and test plans.Strong knowledge of dimensional and functional testing methods.Outstanding skills in using quality inspection tools and software.Excellent interpersonal skills and strict adherence to quality standards.Capacity to support and resolve compliance during audits.Daring and collaborative attitude towards continuous improvement activities.