Quality Systems Engineer I - MRB/NCMR Automation

RxSight; Aliso Viejo (CA); On-site; USD 90,000 - 140,000; Full time

Job summary

RxSight, an ophthalmic medical technology company in Aliso Viejo, CA, is seeking a Quality Systems Engineer to own MRB/NCMR operations and drive improvements across Manufacturing, Engineering, Supply Chain, and Regulatory Affairs. You will help ensure product quality, regulatory compliance, and robust document control.

The role requires hands-on experience with MRB/NCMR processes, ISO 13485 familiarity, and proficiency with Grand Avenue Software and QAD ERP, plus strong automation skills using

Qualifications

• Bachelor's degree and 3+ years in quality eng/nonconformance or equivalent.
• Experience with MRB/NCMR processes and ISO 13485 familiarity.
• Experience with electronic nonconformance systems (Grand Avenue Software) and QAD ERP a plus.
• Proficient with MS Word/Excel; strong problem solving and teamwork.

Responsibilities

• Review and manage MRB/NCMR activities, coordinating investigations and dispositions.
• Lead cross-functional coordination with Manufacturing, Engineering, Supply Chain, Regulatory Affairs.
• Review nonconformance records for completeness and compliance; support QA questions.
• Track and trend MRB metrics; escalate aging NCMRs as needed.
• Schedule MRB meetings; develop quality KPIs and review trends.

Skills

MRB disposition

Nonconformance control

Root cause investigation

Automation

Zapier

Botable

Education

Bachelor's Degree

Tools

Grand Avenue Software

QAD ERP

Microsoft Word

Microsoft Excel

Smartsheet

Power BI

Job description

RxSight, an ophthalmic medical technology company in Aliso Viejo, CA, is seeking a Quality Systems Engineer to own MRB/NCMR operations and drive improvements across Manufacturing, Engineering, Supply Chain, and Regulatory Affairs. You will help ensure product quality, regulatory compliance, and robust document control.

The role requires hands-on experience with MRB/NCMR processes, ISO 13485 familiarity, and proficiency with Grand Avenue Software and QAD ERP, plus strong automation skills using