Contract Regulatory Affairs Quality Engineer — Irvine, CA

Akkodis; Irvine (CA); On-site; USD 55,000 - 56,000; Part time

Job summary

Akkodis in Irvine, CA is seeking a Regulatory Affairs Quality Specialist/Engineer for a contract role onsite. The position requires 3–5+ years of experience and supports QMS implementations, regulatory inspections, and cross-functional projects. Pay is competitive and the assignment is 12 months+ with possible extension.

The candidate will manage CAPA, risk management, RCA, and data analysis, and will use Excel, PowerPoint, and visualization tools to report updates to leadership.

Qualifications

• Strong understanding of QMS and regulatory standards (ISO 13485, FDA 21 CFR Part 820/QMSR, MDSAP, GMP) and their business impact.

Responsibilities

• Implement and maintain QMS per ISO 13485 and applicable regulations.
• Lead CAPA, risk management (ISO 14971), and investigations.
• Support regulatory inspections and internal audits.
• Collaborate cross-functionally on multiple quality/regulatory projects.
• Develop KPIs and provide management with performance insights.

Skills

QMS knowledge

CAPA

Root Cause Analysis

FMEA

Data analysis

KPI development

Project management

Excel

PowerPoint

Data visualization

Cross-functional work

Education

Bachelor's degree in Engineering/Life Sciences

Tools

Microsoft Excel

Microsoft PowerPoint

Data visualization tools

Job description

Akkodis in Irvine, CA is seeking a Regulatory Affairs Quality Specialist/Engineer for a contract role onsite. The position requires 3–5+ years of experience and supports QMS implementations, regulatory inspections, and cross-functional projects. Pay is competitive and the assignment is 12 months+ with possible extension.

The candidate will manage CAPA, risk management, RCA, and data analysis, and will use Excel, PowerPoint, and visualization tools to report updates to leadership.