Glaukos Corporation
Quality Control Inspector I - 2nd shift
Glaukos Corporation, San Clemente, California, us, 92674
GLAUKOS - QUALITY CONTROL INSPECTOR I - 2 ND
SHIFT (SAN CLEMENTE, CA)How will you make an impact?The Quality Control Inspector I will be responsible for all aspects of inspection (receiving, in-process and final). In addition, this position will provide QSR support for other QA activities such as calibration, environmental monitoring, product testing, label control, etc.What will you do?Receiving InspectionReceiving inspection of components following procedures, specifications and drawings.Utilize a variety of standard metrology equipment, including: Optical comparator, height gauge, master height gauge, CMM, Vision Metrology System (VMS, e.g., Smartscope), calipers, micrometers, surface table, gauge blocks, pin gauges, dial indicators, durometer, measuring microscope, hardness testers, pull force testers, surface roughness testers, etc.Read engineering drawings and interpret geometric dimensioning and tolerancing.Review associated paperwork, complete inspection records using good documentation practices, and release components.Program the Smartscope to run automatic routines for multiple part inspections. (Level 2 and higher)Write clear and concise procedures for inspection of components, machined tubing, etc. (Level 2 and higher)Carefully handle and process extremely small components without damaging them.In-Process InspectionPerform Line Clearance for Operations activitiesInspect and release labelingReview device history records for lot release. Ensure all quality records meet good documentation practices in accordance with internal procedures.Perform inspections on components and assemblies in manufacturingFinal InspectionReview device history records for lot release. Ensure all quality records meet good documentation practices in accordance with internal procedures.Perform final inspection on finished goodsInspect finished goods for proper labels, packaging, tamper seals and product in accordance with procedures.Coordinate final inspection activities with outside vendors, i,e, LAL, peel testingPerform in-house peel testing on sealed packagesMaintain sample retain areaOther DutiesWork with engineering in the design of high quality inspection / metrology fixtures.Support equipment and process validation activities by inspecting process outputsConduct periodic compliance audits of manufacturing operations and procedures for cGMP compliance.Ensures on a daily basis quality records and company practices are compliant with internal procedures and regulations.Coordinate the monthly environmental monitoring of the cleanrooms.Coordinate quarterly dose audits.How will you get here?High School Diploma required.0-2 years industry experience.Knowledge, Skills, and AbilitiesMedical device experience and working knowledge of QSR a mustExperience working in a clean room and/or performing in-process assembly and manufacturing verification inspections desirableAttention to detail and accuracy a mustMust have excellent documentation skillsTeam player, good written/oral communicatorMust be organized and able to coordinate activities with outside vendors#GKOSUS
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SHIFT (SAN CLEMENTE, CA)How will you make an impact?The Quality Control Inspector I will be responsible for all aspects of inspection (receiving, in-process and final). In addition, this position will provide QSR support for other QA activities such as calibration, environmental monitoring, product testing, label control, etc.What will you do?Receiving InspectionReceiving inspection of components following procedures, specifications and drawings.Utilize a variety of standard metrology equipment, including: Optical comparator, height gauge, master height gauge, CMM, Vision Metrology System (VMS, e.g., Smartscope), calipers, micrometers, surface table, gauge blocks, pin gauges, dial indicators, durometer, measuring microscope, hardness testers, pull force testers, surface roughness testers, etc.Read engineering drawings and interpret geometric dimensioning and tolerancing.Review associated paperwork, complete inspection records using good documentation practices, and release components.Program the Smartscope to run automatic routines for multiple part inspections. (Level 2 and higher)Write clear and concise procedures for inspection of components, machined tubing, etc. (Level 2 and higher)Carefully handle and process extremely small components without damaging them.In-Process InspectionPerform Line Clearance for Operations activitiesInspect and release labelingReview device history records for lot release. Ensure all quality records meet good documentation practices in accordance with internal procedures.Perform inspections on components and assemblies in manufacturingFinal InspectionReview device history records for lot release. Ensure all quality records meet good documentation practices in accordance with internal procedures.Perform final inspection on finished goodsInspect finished goods for proper labels, packaging, tamper seals and product in accordance with procedures.Coordinate final inspection activities with outside vendors, i,e, LAL, peel testingPerform in-house peel testing on sealed packagesMaintain sample retain areaOther DutiesWork with engineering in the design of high quality inspection / metrology fixtures.Support equipment and process validation activities by inspecting process outputsConduct periodic compliance audits of manufacturing operations and procedures for cGMP compliance.Ensures on a daily basis quality records and company practices are compliant with internal procedures and regulations.Coordinate the monthly environmental monitoring of the cleanrooms.Coordinate quarterly dose audits.How will you get here?High School Diploma required.0-2 years industry experience.Knowledge, Skills, and AbilitiesMedical device experience and working knowledge of QSR a mustExperience working in a clean room and/or performing in-process assembly and manufacturing verification inspections desirableAttention to detail and accuracy a mustMust have excellent documentation skillsTeam player, good written/oral communicatorMust be organized and able to coordinate activities with outside vendors#GKOSUS
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