Quality Systems Engineer — QMS & CAPA Expert

Lighteum Medical; San Diego (CA); On-site; USD 100,000 - 110,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

401(k) with company match

Paid time off

Job summary

Lighteum Medical is seeking a Quality Systems Engineer to maintain and improve the QMS per ISO 13485 at the San Diego site. You will own NCMR, CAR, and internal audits, driving root-cause investigations and corrective actions across cross-functional teams in manufacturing.

The role emphasizes data-driven quality improvements, metrics reporting, and regulatory compliance to ensure product quality for MedTech components.

Qualifications

• Bachelor's Degree in Engineering or related technical field or equivalent Quality engineering experience.
• ASQ Certified Quality Engineer recommended.
• Minimum of 3 years of experience in a manufacturing environment.
• Working knowledge of ISO 13485.
• Experience with customer and cross-functional teams on manufacturing and process improvement initiatives.

Responsibilities

• Supports ISO 13485 compliance through effective QMS implementation and maintenance.
• Owns NCMR process including containment, investigation, disposition, and closure.
• Monitors nonconformances, investigations, corrective actions, and QMS metrics.
• Owns CAR process including root-cause analysis, corrective actions, and effectiveness verification.
• Investigates nonconformities using data-driven risk-based methods.
• Ensures documentation in QMS is accurate and timely.
• Plans and conducts internal audits and verifies effectiveness of actions.
• Develops and maintains QMS metrics and trend reports.
• Collaborates with Production, Engineering, and Quality to resolve issues.

Skills

Quality engineering

Cross-functional teamwork

Root-cause analysis

CAPA/CAR processes

NCMR management

Education

Bachelor's Degree in Engineering or related technical field

ASQ Certified Quality Engineer

Tools

MSA

FMEA

Process flow diagrams

Control Plans

Job description

Lighteum Medical is seeking a Quality Systems Engineer to maintain and improve the QMS per ISO 13485 at the San Diego site. You will own NCMR, CAR, and internal audits, driving root-cause investigations and corrective actions across cross-functional teams in manufacturing.

The role emphasizes data-driven quality improvements, metrics reporting, and regulatory compliance to ensure product quality for MedTech components.