Senior Quality Engineer – MedTech & Process Excellence

RxSight, Inc.; Aliso Viejo (CA); On-site; USD 105,000 - 120,000; Full time

Job summary

RxSight, Inc. in Aliso Viejo, CA seeks a Senior Quality Engineer I to ensure product safety across design, development, manufacturing and post-market stages. You will lead investigations, CAPA activities, and drive quality system improvements in a regulated medical device environment.

Responsibilities include validation support (IQ/OQ/PQ), change control, risk management, data analysis and collaboration with cross-functional teams to maintain ISO 13485 compliance and QSR alignment.

Qualifications

• BS degree in engineering or science.
• 5+ years of QA/regulatory affairs experience in medical devices.
• Knowledge of ISO 13485 and QSR requirements.

Responsibilities

• Lead quality investigations and CAPA.
• Support IQ/OQ/PQ validation activities.
• Manage change control and document control workflows.
• Analyze manufacturing quality data to identify trends and prevent escapes.
• Coordinate internal and external audits and host auditor visits.
• Mentor junior quality engineers and manufacturing personnel.
• Promote a culture of quality ownership on the manufacturing floor.
• Collaborate cross-functionally to maintain regulatory compliance.

Skills

Quality engineering

CAPA

FMEA

root cause analysis

statistical analysis

Education

Bachelor's degree in engineering or science

Tools

Microsoft Excel

Statistical software

Job description

RxSight, Inc. in Aliso Viejo, CA seeks a Senior Quality Engineer I to ensure product safety across design, development, manufacturing and post-market stages. You will lead investigations, CAPA activities, and drive quality system improvements in a regulated medical device environment.

Responsibilities include validation support (IQ/OQ/PQ), change control, risk management, data analysis and collaboration with cross-functional teams to maintain ISO 13485 compliance and QSR alignment.