Lead Quality Engineer, Medical Devices - Hybrid Irvine

Kelly Services; Irvine (CA); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401K

Paid time off

Job summary

Kelly Science & Clinical FSP is seeking a Quality Engineer for a hybrid role in Irvine, California. The engineer will drive quality system effectiveness, lead cross-functional projects, and support regulatory compliance for our medical device client.

Ideal candidates have a strong background in QMS, ISO 13485, FDA 21 CFR Part 820, and experience with CAPA, risk management, and data-driven improvement. Hybrid onsite role with occasional travel to San Diego.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Quality, or related field.
• 4+ years of experience in Medical Device, Pharmaceutical, Biotech, or regulated healthcare industries.
• Demonstrated experience leading complex quality and compliance initiatives.
• Experience supporting regulatory inspections, audits, and quality system management.
• Experience working in cross-functional teams and managing multiple projects simultaneously.

Responsibilities

• Lead strategic quality and compliance initiatives.
• Facilitate risk assessments and drive risk-based decision making.
• Analyze quality data and identify opportunities for improvement.
• Support internal and external audits, inspections, and regulatory activities.
• Lead complex investigations, CAPAs, and continuous improvement programs.
• Manage cross-functional projects to ensure timely execution and sustainable results.
• Provide quality expertise and guidance to business partners and leadership.

Skills

CAPA

Risk management

Root cause analysis

FMEA/PFMEA

Statistical analysis

Process mapping

Fishbone diagram

5 whys

Control plans

Internal auditing

Data visualization

KPI reporting

Education

Bachelor's degree in Engineering, Life Sciences, Quality, or related field

Tools

Excel

PowerPoint

MS Office

Data visualization tools

Job description

Kelly Science & Clinical FSP is seeking a Quality Engineer for a hybrid role in Irvine, California. The engineer will drive quality system effectiveness, lead cross-functional projects, and support regulatory compliance for our medical device client.

Ideal candidates have a strong background in QMS, ISO 13485, FDA 21 CFR Part 820, and experience with CAPA, risk management, and data-driven improvement. Hybrid onsite role with occasional travel to San Diego.