Quality Control Line Inspector II

Glaukos is an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures designed to transform the treatment of glaucoma, one of the world's leading causes of blindness. We have pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. We launched the iStent, our first MIGS device, in the United States in July 2012 and we are leveraging our platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression. We believe the iStent is the smallest medical device ever approved by the Food and Drug Administration, or FDA, measuring 1.0 mm long and 0.33 mm wide.

Position Overview

This QC inspector is responsible for in process inspection to ensure that the quality of product as well as documentation meets Glaukos requirements. This position shall maintains quality standards by approving/releasing in-process production products and recording quality results

Responsibilities

  • Ensures on a daily basis quality records and company practices are compliant with internal procedures and regulations.
  • Performs line clearance for operation 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.
  • Approves in-process production by confirming specifications; conducting visual and measurement tests; communicating required adjustments to production supervisor.
  • Consistently records quality related results in accordance with prescribed good documentation practices requirements.
  • Determines the need and executes the halting of operations due to adverse quality conditions in an effective and timely manner
  • Maintain a safe work environment by following good housekeeping and company guidelines for safety; ability to use tools and equipment safely
  • Reports quality issues or findings follows up to ensure that corrective actions are executed in a timely manner.
  • Initiates Non-Conformity Reports (NCRs), and follows up for Completion of Disposition.

    Experience

Level - I
  • Prefer 1years of medical assembly experience in a medical device company or a minimum of one year experience within a GMP compliant industry.

Level - II
  • At least 3 years of medical assembly experience in a medical device company.

Level - III
  • At least 8 years of medical assembly experience in a medical device company.

Lead
  • At least 10 years of experience, preferably in a medical assembly in a medical device company utilizing an MRP system.
  • Demonstrating increasing responsibility.


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
  • Familiar with AQL sampling or sampling plans in general, visual and dimensional inspection.
  • Ability to work in a fast-paced environment.
  • Basic inspection knowledge using See-Mic or equivalent measurement equipment is a plus.


Education

High school Graduate, some College preferred

We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, 3 weeks paid time off, 13 company paid holidays, Employee Stock Purchase Program and 2 additional paid days off to volunteer in our community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class. Check out our profile on The Muse to get an inside look at our company culture: https://www.themuse.com/companies/glaukoscorporation

Glaukos has been recognized by the Orange County Business Journal as one of the best companies to work for in in Orange County, check out page 8 at http://www.cbjonline.com/a1ocbj/lists/List-2017-OC_Best-Places-to-Work.pdf

EEO Statement: Glaukos Corporation is an Equal Opportunity/Affirmative Action/E-Verify employer.


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