Senior Quality Engineer - MedTech Manufacturing

RxSight; Aliso Viejo (CA); On-site; USD 110,000 - 140,000; Full time

Job summary

RxSight, based in Aliso Viejo, California, is seeking a Senior Quality Engineer I to lead quality assurance across manufacturing, development and post-market activities for ophthalmic devices.

You will drive CAPA, investigations, validation (IQ/OQ/PQ), change control, and risk management per ISO 13485 and QSR requirements, collaborating with cross-functional teams to ensure product safety and regulatory compliance.

Qualifications

• BS degree in engineering or science.
• 5+ years of experience performing quality assurance/regulatory affairs in a manufacturing and/or product development environment, preferably medical devices.
• Training to be completed per the training plan for this position.

Responsibilities

• Lead investigations and CAPA for manufacturing quality.
• Support IQ/OQ/PQ validation protocol development and execution.
• Manage change control for manufacturing and process changes.
• Collaborate with Manufacturing, Engineering, Regulatory Affairs on change approvals.
• Analyze quality data to prevent escapes and improve metrics.
• Assist with internal and external audits and close findings.

Skills

Issue identification

Ownership & accountability

Process mastery

Interpersonal skills

Problem solving

Education

BS degree in engineering or science

Tools

Spreadsheets and docs

Statistical analysis software

Job description

RxSight, based in Aliso Viejo, California, is seeking a Senior Quality Engineer I to lead quality assurance across manufacturing, development and post-market activities for ophthalmic devices.

You will drive CAPA, investigations, validation (IQ/OQ/PQ), change control, and risk management per ISO 13485 and QSR requirements, collaborating with cross-functional teams to ensure product safety and regulatory compliance.