Senior Quality Engineer I

RxSight, Inc.•Aliso Viejo, CA

3d•Onsite

About The Position

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

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
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.

Nice To Haves

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

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.