How will you make an impact?
The Supervisor Quality Assurance (QA) 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.
Quality System Maintenance:
* 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.
This position will also perform other duties as assigned.
How will you get here?
Experience
* Bachelor's Degree
* 2-5+ years of relevant work experience
* 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
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