Quality Systems Engineer I: MRB/NCMR & Automation

RXSIGHT INC; Aliso Viejo (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

RxSight in Aliso Viejo, CA, seeks a Quality Systems Engineer to own MRB/NCMR operations, coordinating investigations, dispositions, and closure across Manufacturing, Engineering, Supply Chain, and Regulatory Affairs.

You will drive automation within QA systems using Zapier and Botable, support electronic system updates, and ensure ISO 13485 and 21 CFR 820 compliance across global markets.

Qualifications

• Bachelor's degree and 3+ years of quality engineering/nonconformance experience.
• Experience with nonconforming material control, MRB disposition processes, and root cause investigations.
• Experience with electronic nonconformance/MRB systems (Grand Avenue Software or equivalent) and QAD (ERP) a plus.

Responsibilities

• Review and manage MRB/NCMR activities, coordinating investigations, dispositions, and closure.
• Coordinate with Manufacturing, Engineering, Supply Chain, and Regulatory Affairs for investigations and implementations.
• Review nonconformance records for completeness, accuracy, and compliance.
• Track, report, and trend nonconformance metrics and escalate aging/open NCMRs.
• Schedule and host MRB meetings and review quality metrics/KPIs.
• Support updates to electronic systems and data controls.
• Lead automations within existing systems to streamline workflows using Zapier and Botable.

Skills

MRB/NCMR management

Automation (Zapier/Botable)

Grand Avenue Software

Smartsheet

Power BI

MS Office (Word/Excel)

Quality systems knowledge

Cross-functional collaboration

Education

Bachelor's Degree in a related field

Tools

Grand Avenue Software (GAS)

Zapier

Botable

QAD (ERP)

Smartsheet

Job description

RxSight in Aliso Viejo, CA, seeks a Quality Systems Engineer to own MRB/NCMR operations, coordinating investigations, dispositions, and closure across Manufacturing, Engineering, Supply Chain, and Regulatory Affairs.

You will drive automation within QA systems using Zapier and Botable, support electronic system updates, and ensure ISO 13485 and 21 CFR 820 compliance across global markets.