Quality System Lead - Global Logistics (Irvine)

Tri-Valley Career Center; Irvine (CA); On-site; USD 86,000 - 119,200; Full time

Benefits offered by this job

Medical plans

Free HSA funds

401k with company match

Profit sharing

Employee stock purchase program

Job summary

Bio‑Rad Laboratories, Inc. in Irvine, California, seeks a Quality System Specialist to lead and improve the Global Logistics QMS, ensuring regulatory compliance with GDP, ISO9001 and ISO13485 requirements.

You will manage QMS performance data, coordinate internal audits, serve as the Quality Management Representative, and drive corrective actions and continuous improvement across functions and regions.

Qualifications

• Bachelor’s degree in Engineering, Biology, Chemistry, or related discipline.
• 3–5 years in a regulated distribution/warehouse environment with GDP/ISO9001/ISO13485.
• 2+ years ERP experience (SAP or Oracle).
• Experience developing and implementing QMS processes.

Responsibilities

• Analyze and communicate QMS performance data.
• Ensure regulatory requirements are understood across the organization.
• Promote risk-based approaches and drive continuous improvement.
• Coordinate and manage internal audits; be the primary contact for audits.
• Lead the QA function and manage site QMS documentation.

Skills

Quality systems experience

ERP (SAP/Oracle)

QMS implementation

Audit management

Leadership

Regulatory knowledge

Continuous improvement

Communication

Project management

Education

Bachelor’s degree in Engineering, Biology, Chemistry, or related discipline

Tools

SAP

Oracle

Job description

Bio‑Rad Laboratories, Inc. in Irvine, California, seeks a Quality System Specialist to lead and improve the Global Logistics QMS, ensuring regulatory compliance with GDP, ISO9001 and ISO13485 requirements.

You will manage QMS performance data, coordinate internal audits, serve as the Quality Management Representative, and drive corrective actions and continuous improvement across functions and regions.