Quality Engineer - ISO QMS & CAPA Expert

Applied Fluid Power; Newark (CA); On-site; USD 95,000 - 115,000; Full time

Job summary

Bay Advanced Technologies, an Applied Fluid Power subsidiary, is seeking a Quality Engineer to join our Newark, CA team. You will support the QMS for ISO 9001 and ISO 13485, managing CAPA, audits, and documentation to enhance product and process quality across Bay sites.

You will collaborate with Engineering and suppliers to implement quality improvements, perform root-cause analysis, and ensure compliance with RoHS/TSCA/REACH/PFAS requirements.

Qualifications

• BS in Mechanical, Electrical, or Materials Engineering.
• 2–5 years of Manufacturing Quality/ISO 9001/13485 experience.
• Knowledge of PFMEA and DFMEA desirable.

Responsibilities

• Perform root cause analysis for CAPA reports and implement corrective actions; submit CAPA reports to customers.
• Perform supplier QMS/process audits and ensure product manufacturing controls.
• Collaborate with suppliers to resolve product quality issues and drive closures.
• Update QMS documents for Newark, Singapore and Austin sites.
• Support QMS internal audits for Newark, Singapore and Austin.
• Update documents in Document Control and QMS for Bay sites.

Skills

Quality Management

ISO 9001/13485

Root Cause Analysis

Documentation Control

Cross-Functional Collaboration

Education

BS in Mechanical Engineering

BS in Electrical Engineering

BS in Materials Engineering

Tools

ERP (P21)

PLM Systems

Mechanical CAD

Job description

Bay Advanced Technologies, an Applied Fluid Power subsidiary, is seeking a Quality Engineer to join our Newark, CA team. You will support the QMS for ISO 9001 and ISO 13485, managing CAPA, audits, and documentation to enhance product and process quality across Bay sites.

You will collaborate with Engineering and suppliers to implement quality improvements, perform root-cause analysis, and ensure compliance with RoHS/TSCA/REACH/PFAS requirements.