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, 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.