Quality Systems Engineer — Onsite in San Diego

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

Benefits offered by this job

Health insurance

401(k) with company match

Paid time off

Job summary

Lighteum Medical in San Diego, CA is seeking a Quality Systems Engineer to maintain and enhance the site's QMS under ISO 13485. This role focuses on NCMR, CAPA, internal audits, and quality metrics, working with Operations and Engineering across departments.

The ideal candidate will drive investigations, corrective actions, and continuous improvement using data-driven methods and Lean Six Sigma, ensuring product quality and regulatory compliance.

Qualifications

• Bachelor's degree in engineering or related field; CQE certification is a plus.
• Minimum 3 years manufacturing experience in a regulated environment.
• Working knowledge of ISO 13485 and quality systems fundamentals.
• Experience with NCMR/CAR/ CAPA processes and audits.
• Ability to read engineering drawings and quality documentation.
• Strong communication and cross-functional collaboration skills.
• Lean Six Sigma tools and problem-solving methodologies.

Responsibilities

• Maintain and improve the Quality Management System (QMS) per ISO 13485.
• Own nonconforming material (NCMR) and corrective actions (CAR/ CAPA).
• Plan and conduct internal quality audits and track corrective actions.
• Develop and monitor QMS metrics and trends.
• Collaborate with Operations, Engineering, and Quality to resolve issues.

Skills

3+ years manufacturing experience

ISO 13485 knowledge

NCMR/CAPA processes

Internal audits

Root cause analysis

Data-driven investigations

Cross-functional teamwork

Strong communication skills

Lean Six Sigma

Education

Bachelor's Degree in Engineering or related field

ASQ Certified Quality Engineer (CQE)

Job description

Lighteum Medical in San Diego, CA is seeking a Quality Systems Engineer to maintain and enhance the site's QMS under ISO 13485. This role focuses on NCMR, CAPA, internal audits, and quality metrics, working with Operations and Engineering across departments.

The ideal candidate will drive investigations, corrective actions, and continuous improvement using data-driven methods and Lean Six Sigma, ensuring product quality and regulatory compliance.