Quality Engineer: CAPA, Audits & Continuous Improvement

Applied Industrial Technologies; Newark (CA); On-site; USD 130,872,000 - 158,424,000; Full time

Job summary

Bay Advanced Technologies, a subsidiary of Applied Fluid Power, is seeking a Quality Engineer in Newark, CA to support ISO 9001/13485 quality practices for product quality, supplier and customer quality issues, audits, and documentation. You will drive CAPA, 8D reporting, and continuous improvements.

Responsibilities include supplier QMS audits, internal audits, QMS document control, and collaboration with Engineering to implement quality improvements across sites.

Qualifications

• BS in Mechanical, Electrical, or Materials Engineering.
• 2–5 years of Manufacturing Quality/ISO 9001/13485 experience in relevant fields/industry.
• Ability to map manufacturing and test processes to identify gaps causing product quality non-conformances.

Responsibilities

• Perform root cause analysis for customer CAPA reports and implement internal corrective actions.
• Perform supplier QMS/process audits as needed.
• Work with suppliers to resolve product quality issues and drive CAPA closures.
• Support QMS document updates for Newark, Singapore, and Austin sites.
• Support QMS internal audits for Newark, Singapore and Austin.
• Support customer QMS and process audits.
• Update documents in the Document Control and QMS systems.
• Review RMA failure analysis data and WQDR reports to reduce defects and improve yield.
• Support MRB activities and participate in MRB decisions.
• Collaborate with Engineering to update quality-related documents.
• Supervise FAI submissions for Bay customers.

Skills

ISO 9001/13485

QMS knowledge

Engineering practices

Communication skills

Multi-tasking

Interpersonal skills

CAD software

Windows/Office

ERP (P21)

PLM systems

Mechanical drawings

PFMEA/DFMEA

Education

BS in Mechanical/ Electrical/ Materials Eng

Tools

P21 ERP

PLM systems

Job description

Bay Advanced Technologies, a subsidiary of Applied Fluid Power, is seeking a Quality Engineer in Newark, CA to support ISO 9001/13485 quality practices for product quality, supplier and customer quality issues, audits, and documentation. You will drive CAPA, 8D reporting, and continuous improvements.

Responsibilities include supplier QMS audits, internal audits, QMS document control, and collaboration with Engineering to implement quality improvements across sites.