Quality Engineer II - Drive Process Quality & CAPA

Fralock; West Chatsworth (CA); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401k with Company Match

PTO

Job summary

Fralock seeks a Quality Engineer II to sustain our ISO 13485/9001/AS9100 quality systems and lead CAPA, MRB, and process improvements for high-reliability materials. You will partner with Engineering, Manufacturing, and Supply Chain to drive quality from design through production.

This onsite role in Chatsworth requires a strong background in quality engineering, data analysis, and a lean, Six Sigma mindset to reduce defects and improve process capability across diverse programs.

Qualifications

• Bachelor's degree in manufacturing engineering or related field.
• 3–5 years of quality engineering in a regulated environment (ISO 9001, AS9100, and/or ISO 13485).
• Experience with ERP systems such as Made-2-Manage.
• ASQ Certified Quality Engineer preferred.
• Strong analytical and data-driven problem solving.

Responsibilities

• Support QMS compliance including ISO 13485, ISO 9001, and AS9100.
• Define and classify quality characteristics for products, processes, and services.
• Lead change control and document change orders.
• Oversee MRB and disposition of nonconforming materials.
• Investigate nonconformances and implement CAPA actions.
• Drive Six Sigma and lean improvements to reduce defects.
• Support First Article Inspection and customer quality requirements.
• Conduct internal audits and risk assessments (PFMEA/FMEA).

Skills

Quality processes

CAPA

Six Sigma

Lean manufacturing

Data analysis

GD&T

Problem solving

Communication

ERP systems

MS Excel

Education

Bachelor's degree in manufacturing engineering or related field

3–5 years in a regulated environment (ISO 9001/AS9100/ISO 13485)

Experience with ERP systems (e.g., Made-2-Manage)

ASQ Certified Quality Engineer (preferred)

Tools

Made-2-Manage

Minitab

Job description

Fralock seeks a Quality Engineer II to sustain our ISO 13485/9001/AS9100 quality systems and lead CAPA, MRB, and process improvements for high-reliability materials. You will partner with Engineering, Manufacturing, and Supply Chain to drive quality from design through production.

This onsite role in Chatsworth requires a strong background in quality engineering, data analysis, and a lean, Six Sigma mindset to reduce defects and improve process capability across diverse programs.