Director, Product Quality & Validation

System One; San Diego (CA); On-site; USD 200,000 - 240,000; Full time

Benefits offered by this job

Health and welfare benefits

401(k) plan

Job summary

System One in San Diego, CA is seeking an experienced Director of Product Quality to lead the Quality Engineering and QC functions across development, manufacturing, supplier quality, and sustaining operations.

The ideal candidate will have deep expertise in quality systems, CAPA, validation, risk management, statistics, and root cause investigations within IVD, Medical Device, or Pharmaceutical industries, and possess hands-on leadership experience with 15+ years in QE/QC and 10+ years of

Qualifications

• Bachelor’s degree in engineering or related field.
• 15+ years of relevant work experience in QE/QC.
• Minimum 10 years of supervisory experience.
• Experience in IVD/Medical Device or Pharma preferred.

Responsibilities

• Lead Quality Engineering for new product and sustaining activities.
• Oversee Quality Control labs and QC release processes.
• Strengthen CAPA effectiveness and root cause analysis.
• Drive continuous improvement and risk management initiatives.
• Collaborate with Manufacturing, R&D, and Supply Chain to improve quality.

Skills

Leadership

Quality systems

Root cause analysis

CAPA

Risk management

Statistical analysis

Education

ASQ Certified Quality Engineer

Tools

Statistical tools

Design controls

Job description

System One in San Diego, CA is seeking an experienced Director of Product Quality to lead the Quality Engineering and QC functions across development, manufacturing, supplier quality, and sustaining operations.

The ideal candidate will have deep expertise in quality systems, CAPA, validation, risk management, statistics, and root cause investigations within IVD, Medical Device, or Pharmaceutical industries, and possess hands-on leadership experience with 15+ years in QE/QC and 10+ years of