Senior Quality Engineer I

Overview

The Senior Quality Engineer I position at RxSight® requires significant learning agility and adaptability to operate in a highly dynamic and innovative environment. This role supports the design and development, manufacturing, and post-market quality processes, ensuring product safety and compliance with regulatory requirements.

Responsibilities

• Support manufacturing operations by 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.
• Influence quality strategy by identifying systemic gaps and leading cross-functional initiatives that simplify processes while maintaining regulatory compliance.

Requirements

• Able to identify issues/gaps and come up with solutions for identified issues.
• Takes initiative and ownership/accountability for their work.
• 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.

Education, Experience, And Training

• BS 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, Licenses, Registrations

• ASQ certification (CQA, CMDA, CQE, CSQP) or RAC recommended but not required.

Computer Skills

• Competent in use of spreadsheets and documents.
• Competent in preparing presentations.
• Competent in use of statistical trending software.