Quality Controller
Full-time
Description
Work Flexibility: Onsite<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p>The aim of this job is to Perform inspection of manufacturing goods during the manufacturing process. Conducts dimensional and electrical inspection of sub-assemblies or final systems assemblies. Interprets prints, manufacturing drawings, diagrams, wire cards and lists in approving or rejecting in-process or final assemblies.</p><p></p><p><b>What you will do</b>:</p><ul><li>Perform dimensional and/or visual inspection to blueprint using gauges and other reliant inspection equipment.</li><li>Perform material and component inspections.</li><li>Perform First Article Inspection (FAI) and verify FAI data (incl. statistical analysis) is acceptable.</li><li>Read and inspect to blueprints and/or inspection guide sheets / instructions.</li><li>Perform Document Review, analyze, inspect and archive DHRs (paper-based and/or electronically) in compliance to GMP/GDP requirements prior to release to finished goods.</li><li>Maintain the compliance of the control and measurement equipment base, along with managing their calibration.</li><li>Train staff in the use of control and measurement equipment</li><li>Perform computer system transactions related to router inspections, etc.</li><li>Segregate, quarantine and complete documentation for non-conforming materials when necessary<i>. </i></li><li>Initiation of quarantine tickets (non-conformance reports)</li><li>Perform disposition tasks in the ERP system.</li><li>Support the achievement of Inspection Teams’ KPI's.</li><li>Support in non-conformance handling and analysis</li><li>Work to forecasts and plans based on Business requirements.</li><li>Processing of changes in relation to test process</li><li>Gauge management , support of gauge validation</li><li>Support in processing deviation reports (non-conformity reports in eCAPA, -D reports to supplier quality , etc.)</li><li>Introduction of new employees for quality standard</li></ul><p></p><p><b>Good to have: </b></p><ul><li>High School Diploma of technical education</li><li>2+ years of work experience in a similar position (preferred ISO 13485/ cGMP manufacturing environment) </li><li>Ability to read the drawings and specifications exhibited </li><li>High proficiency in the use of all standard inspection equipment including calipers, micrometers, microscope, gages and comparators </li><li>Proficiency in the use of coordinate measuring machines, electrical / visual inspection techniques. </li><li>Proficiency in understanding of Inspection Sampling Plans </li><li>Ability to build proficiency in GD&T (Geometric Dimensioning and Tolerancing) </li><li>Ability to build basic proficiency of FDA CFR 820 and ISO 13485 Regulations </li><li>Preferred ability to lift up to 12 kg an occasional </li><li>English (speaking and writing) as plus</li></ul><p></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>Travel Percentage: 10%<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p></p><p></p><p></p><p></p>