Job Description
How will you make an impact?
The Quality Assurance (QA) Supervisor will provide engineering support and conduct activities to approve incoming inspection and manufacturing of Class III medical devices. This individual will work with cross functional departments to resolve product quality (mainly incoming inspection) issues. The QA Supervisor will ensure all procedures and records meet regulatory and Glaukos requirements.
What will you do?
Receiving Inspection:
- Manage the daily activities of the department personnel by setting priorities, coordinating activities to meet project deadlines, and troubleshooting technical difficulties.
- Monitor inspection activities to ensure compliance to internal procedures.
- Compile data and provides reports to monitor health of the RI function.
- Investigate and disposition nonconforming components identified during receiving inspection.
- Initiate and investigate NCR and CAPA as appropriate.
- Assist engineering in choosing proper metrology equipment such as 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.
- Provide feedback to suppliers through the SCAR process.
- Monitor inspection results and ensure tightening or reducing AQLs are performed according to procedure.
- Assist, mentor, and guide inspectors as needed to achieve program goals.
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- Review supporting documentation for component and process changes at suppliers and component drawings and specification at Glaukos.
- Monitor and ensure procedures for receiving inspection are being adhered to and in compliance with regulations.
- Support the Quality System, including the CAPA process, collaborating with owners to ensure effective root cause analysis and the development of innovative, long-term solutions.
- Lead process improvements in the area of receiving inspection including corrective and preventive actions and responding to audit findings.
How will you get here?
- High School Diploma or GED required.
- 8+ years of relevant work experience with High School diploma
- 5+ years of relevant work experience with Bachelor's degree
- Knowledge of medical device manufacturing preferred
- Working understanding of GDP, GMP and ISO 13485 requirements
- Experience in GD&T. Able to program CMM and Smartscope is preferred.
- Working knowledge of statistics as it applies to verification/ validation testing and process control, and previous use of statistical analysis software, such as Minitab
- A work style of hands-on involvement with all phases of projects
- Excellent documentation skills, attention to detail and accuracy
- Team player, flexible multitask, good written/oral communicator
- Must be organized and able to coordinate activities with internal departments and outside vendors
- Experience in supplier audit and ASQ certification is a plus
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.