Senior Quality Engineer I

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 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.

Requirements

ESSENTIAL 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 ABILITIES:

• Able to identify issues/gaps and come up with solutions for identified issues
• Takes initiative and ownership/accountability for their work
• Able to quickly master specific processes/programs and apply learned concepts to other disparate, new areas
• Knowledgeable of quality management system (ISO 13485) requirements
• 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 complaint, CAPA, training, non-conformances, change control, engineering change requests, and other quality systems

SUPERVISORY RESPONSIBILITI