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Quality Control Inspector I

1 month ago

San Clemente, California, United States Glaukos Full time
Job Description GLAUKOS - QUALITY CONTROL INSPECTOR I - 2ND 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 Inspection
  • Receiving 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 Inspection
  • Perform Line Clearance for Operations activities
  • Inspect and release labeling
  • Review 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 manufacturing
Final Inspection
  • Review device history records for lot release. Ensure all quality records meet good documentation practices in accordance with internal procedures.
  • Perform final inspection on finished goods
  • Inspect 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 testing
  • Perform in-house peel testing on sealed packages
  • Maintain sample retain area
Other Duties
  • Work with engineering in the design of high quality inspection / metrology fixtures.
  • Support equipment and process validation activities by inspecting process outputs
  • Conduct 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 Abilities
  • Medical device experience and working knowledge of QSR a must
  • Experience working in a clean room and/or performing in-process assembly and manufacturing verification inspections desirable
  • Attention to detail and accuracy a must
  • Must have excellent documentation skills
  • Team player, good written/oral communicator
  • Must be organized and able to coordinate activities with outside vendors
#GKOSUS About Us Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible. Founded in 1998, Glaukos Corporation is an ophthalmic pharmaceutical and medical technology company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases. Our mission at Glaukos is to truly transform vision by pioneering novel, dropless therapies that can meaningfully advance the standard of care and improve the lives of patients suffering from chronic, sight-threatening eye diseases. Innovation is at the core of everything we do, and we are resolute in our commitment to challenge conventional thinking with new treatment alternatives that are supported by real science, robust clinical evidence, and an unrelenting focus on patients. Our constant pursuit of game-changing technologies that disrupt legacy treatment paradigms is encapsulated in the Glaukos mantra "We'll Go First," which articulates our willingness to take chances, our determination to forge new ground, and our commitment to continuous improvement in all that we do. Our company completed an initial public offering in June of 2015, and our shares are traded on the New York Stock Exchange under the ticker symbol "GKOS". Our global headquarters is in Aliso Viejo, California with additional locations in San Clemente, California, and Burlington, Massachusetts. Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer . All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law. Glaukos