Senior Quality Engineer I

DescriptionRxSight® is an ophthalmic medical technology corporation headquartered in Aliso Viejo, California that has commercialized the world’s first and only adjustable intraocular lens (IOL) that is customized after cataract surgery. The company’s mission is to revolutionize the premium cataract surgery experience by allowing surgeons to partner with their patients to achieve optimized results for every unique eye.OverviewThe Senior Quality Engineer I position requires significant learning agility and adaptability to successfully operate in a highly dynamic and innovative environment. The Senior Quality Engineer I will be responsible for ensuring product safety by supporting the design and development, manufacturing, and post-market and quality processes. Responsibilities will include leading and documenting investigations and failure analysis as required and ensuring information flows back into the design and development and risk management processes. The Senior Quality Engineer I will support all RxSight products and will be expected to apply knowledge of process engineering, risk management, and quality engineering techniques to innovate and improve quality system processes while simultaneously ensuring conformance to applicable regulatory requirements.In addition, the Senior Quality Engineer I will set up and manage Good Manufacturing Practices in support of production and implement and maintain policies and procedures to ensure compliance with Quality System Regulations (QSR’s) for medical devices. The Senior Quality Engineer I 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 collaborate with Product Development, Manufacturing, and other cross-functional teams to ensure product quality and regulatory compliance.RequirementsESSENTIAL DUTIES AND RESPONSIBILITIES:Serve as the primary Quality Engineering support for manufacturing operations, ensuring products are built in compliance with applicable regulatory requirements.Provide real-time quality support to manufacturing, including review and disposition of nonconforming material, execution of root cause investigations, and implementation of effective corrective and preventive actions (CAPA).Lead and support validation activities (IQ/OQ/PQ), including protocol development, execution oversight, deviation assessment, and validation reporting for new and existing manufacturing processes.Partner cross-functionally with Manufacturing, Engineering, Supplier Quality, and Regulatory Affairs to assess and approve manufacturing and process changes through change control.Drive continuous improvement initiatives using risk-based and data-driven methodologies (e.g., FMEA, SPC, DOE, Pareto analysis) to improve process capability, product quality, and yield.Author, review, update and approve quality system documentation, including SOPs, work instructions, validation protocols/reports, and quality plans impacting manufacturing operations.Analyze manufacturing quality data, identify adverse trends, and proactively implement actions to prevent escapes, reduce scrap/rework, and improve overall quality metrics.Support internal and external audits, including preparation, direct interaction with auditors, and timely resolution of audit findings.Lead or mentor junior quality engineers and manufacturing personnel on quality principles, regulatory requirements, and best practices in problem solving and risk management.Act as a quality advocate on the manufacturing floor, promoting a culture of quality ownership, compliance, and continuous improvement.Influence quality strategy by identifying systemic gaps and leading cross-functional initiatives that simplify processes while maintaining regulatory compliance.Required Knowledge, Skills And AbilitiesAble to identify issues/gaps and come up with solutions for identified issuesTakes initiative and ownership/accountability for their workAble to quickly master specific processes/programs and apply learned concepts to other disparate, new areasKnowledgeable of quality management system (ISO 13485) requirementsKnowledgeable of requirements for medical devices in US, EU, Mexico, Canada, Australia, Brazil, Japan, and other marketsAble to perform product failure analysisAble to perform basic statistical analysisStrong interpersonal skills, well-established computer, communication, and presentation skillsAble to manage complaint, CAPA, training, non-conformances, change control, engineering change requests, and other quality systemsSupervisory ResponsibilitiesNoneEDUCATION, EXPERIENCE, And TRAININGBS degree in an engineering or science discipline or combined education and experience. 5+ years of experience performing quality assurance/regulatory affairs and developing processes in a manufacturing and/or product development environment preferably in a medical device industry.Training to be completed per the training plan for this position as maintained in the document control system.Certificates, Land Icenses, RegistrationsASQ certification (CQA, CMDA, CQE, CSQP) or RAC recommended but not requiredComputer SkillsCompetent in use of spreadsheets and documentsCompetent in preparing presentationsCompetent in use of statistical trending softwareNotice To Staffing Agencies And Search FirmsRxSight does not accept unsolicited resumes or candidate submissions from staffing agencies or search firms for any employment opportunities. All agency engagements must be authorized in writing for a specific position by RxSight’s Talent Acquisition department. Any resumes or candidate information submitted without such specific engagement will be considered unsolicited and the property of RxSight. No fees will be paid in the event a candidate is hired under these circumstances.Salary Description$105,000 To $120,000 Per Year