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Quality Engineer

Company: RxSight, Inc.
Location: Aliso Viejo
Posted on: May 8, 2022

Job Description:

RxSight has commercialized the world---s first and only adjustable intraocular lens (IOL) that is customized after cataract surgery. This intraocular lens can be adjusted non-invasively while in the eye, allowing the post-cataract surgery patient to see clearly at distance without the use of eyeglasses or contact lenses. The application of light to the implanted Light Adjustable Lens (LAL---) will fine-tune the patient---s lens power to their specific visual need.This technology sets the stage for a series of lens products from RxSight that will have widespread application in cataract and refractive surgery as well as outside the field of medicine. OVERVIEW: The Quality Engineer position requires significant learning agility and adaptability in order to successfully operate in a highly dynamic and innovative environment. The Quality Engineer is responsible for managing the complaint handling process, including all intake, reportability determination, risk assessment, and investigation activities. In addition, the Quality Engineer will set up and manage the Good Manufacturing Practices for the production of RxSight devices and accessories; support the development of RxSight devices and accessories; and develop, implement and maintain policies and procedures to ensure compliance with Quality System Regulations (QSR---s) for medical devices. The Quality Engineer will be responsible for establishing documentation control and approval workflows to support manufacturing and testing for processes, test methods, test results, batch records, etc. for manufacturing and work with Product Development, Manufacturing, and Quality Control departments to ensure product quality and regulatory compliance. ESSENTIAL DUTIES AND RESPONSIBILITIES: -- Manage the intake and follow-up of complaints and other forms of customer feedback -- Investigate or facilitate the investigation of complaints -- Maintain complaint documentation, including reportability decisions, complaint investigations, and all applicable supporting documentation -- Manage the decontamination and disposition of returned materials -- Performs and documents reportability decisions in accordance with applicable regulations -- Monitor complaint data for trends -- Lead the review of all material review board dispositions within functional area -- Read, comprehend and follow documents outlining all procedures related to the light adjustable lens -- Establish and maintain document control practices for the manufacturing area including batch records, data systems, and material release -- Create, review, and maintain risk management files within functional area -- Review test results and release material for use -- Establish and maintain material control practices for the production area -- Perform audits of manufacturing practices to confirm operations to established processes -- Maintain and update equipment development, validation, and installation process -- Control materials for use in manufacturing and non-conforming materials -- Work with suppliers to ensure quality system requirements are understood and successfully met -- Maintain compliance to latest standards for optics, electronics, mechanics, and software as required -- Maintain working knowledge of all U.S. and International standards relating to medical devices including biocompatibility, physico-chemical, optical mechanical, IEC/EMC, ISO, etc. for company as required -- Perform corrective actions and root cause analysis as required -- Initiate change requests and approve change requests -- Support audits as necessary with information from the manufacturing and development areas -- Ensure compliance to company---s product development standards for new product development REQUIRED KNOWLEDGE, SKILLS AND ABILITIES: -- Knowledgeable of 21 CFR 820, 21 CFR 807, 21 CFR 806, and 21 CFR Part 11 -- Knowledgeable of ISO 13485 and 14971 -- Knowledgeable of IEC 60601-1 -- Knowledgeable of requirements for medical devices in US, EU, Mexico, Canada, Australia, Brazil, Japan, and other markets -- Able to perform product failure analysis -- Able to perform basic statistical analysis -- Strong interpersonal skills, well-established computer, communication and presentation skills -- Able to manage complaints, CAPA, training, non-conformances, change control, engineering change requests, and other quality systems Ability to travel up to 25 percent EDUCATION, EXPERIENCE, and TRAINING: -- BS degree in an engineering or science discipline or combined education and experience. -Minimum of 2 years of experience performing quality assurance/regulatory affairs and developing processes in a manufacturing and/or product development environment preferably in the medical device industry. CERTIFICATES, LICENSES, REGISTRATIONS: -- ASQ certification (CQE, CSQP) recommended but not required -- RAC certification recommended but not required

Keywords: RxSight, Inc., Aliso Viejo , Quality Engineer, Engineering , Aliso Viejo, California

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