Associate Quality Engineer - RxSight : Job Details

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Description

RxSight 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.

Overview

The Associate Quality Engineer position requires significant learning agility and adaptability to operate successfully in a highly dynamic and innovative environment. Responsibilities include supporting the complaint handling process to ensure product safety, managing intake, leading investigations, and ensuring information flows back into design, development, and risk management processes. The role supports all RxSight products and involves applying process engineering, risk management, and quality engineering techniques to innovate and improve quality systems while ensuring regulatory compliance.

Additional responsibilities include setting up and managing Good Manufacturing Practices, establishing documentation control workflows, and collaborating with cross-functional teams to ensure product quality and regulatory adherence.

Essential Duties and Responsibilities

• Investigate product complaints
• Monitor post-market data for trends
• Manage complaint intake and disposition of returned materials
• Review device history records and test results
• Establish and maintain material control practices
• Perform corrective actions and root cause analysis
• Create and maintain risk management files
• Perform manufacturing audits
• Establish document control practices
• Initiate and approve change requests
• Lead material review board dispositions
• Maintain equipment validation and installation processes
• Support audits and ensure compliance with standards
• Ensure compliance with product development standards for new products

Requirements

Knowledge, Skills, and Abilities:

• Knowledge of 21 CFR 820, 807, 806, and Part 11
• Knowledge of ISO 13485 and 14971
• Understanding of medical device requirements across multiple markets
• Ability to perform failure analysis and basic statistical analysis
• Strong interpersonal and communication skills
• Experience managing quality systems such as complaint handling, CAPA, change control
• Knowledge of IEC 60601-1

Education, Experience, and Training

• Bachelor's degree in engineering or science or equivalent experience
• At least 1 year of experience in quality assurance/regulatory affairs in a medical device environment
• Completion of required training within specified timelines

Certificates, Licenses, and Registrations

• ASQ certification (CQE, CSQP) or RAC is recommended but not required

Computer Skills

• Proficiency in spreadsheets, documents, and presentation preparation

Salary Range: $70,000 to $85,000 per year

Additional Information

This position is full-time, entry level, within the Medical Equipment Manufacturing industry, focusing on Quality Assurance. No supervisory responsibilities are associated with this role.