Mfg/Ops Quality Engineer 1

Illumina; San Diego (CA); On-site; USD 70,000 - 110,000; Full time

Job summary

Illumina is seeking a Manufacturing and Product Quality Engineer to join the Mfg/Ops Quality team, supporting sustaining activities and quality oversight across manufacturing sites. You will drive GMP-compliant validation, manage non-conformances, facilitate change management, and analyze quality data for process improvements while collaborating with cross-functional teams at multiple sites.

This entry-level role emphasizes regulatory compliance and continuous improvement within a fast-paced

Qualifications

• Bachelor's degree in Engineering or Science required.
• 0–2 years in quality assurance within regulated environments.
• Familiarity with 21 CFR 820 and ISO 13485.
• SAP experience preferred.

Responsibilities

• Ensure GMP-compliant validation.
• Manage non-conformances.
• Facilitate change management.
• Analyze quality data for process improvements.
• Collaborate with cross-functional teams across sites.

Skills

Quality Assurance

GMP compliance

Data analysis

Change management

Cross-functional collaboration

Education

Bachelor's degree in Engineering or Science

Tools

21 CFR 820

ISO 13485

SAP

Job description

Role

Manufacturing and Product Quality Engineer within Illumina's Mfg/Ops Quality team, supporting manufacturing sustaining activities and quality oversight.

Responsibilities

• ensure GMP-compliant validation
• manage non-conformances
• facilitate change management
• analyze quality data for process improvements
• collaborate with cross-functional teams across sites

Requirements

• Bachelor's in Engineering or Science
• 0-2 years in quality assurance in regulated environments
• familiarity with 21CFR 820
• ISO 13485
• SAP preferred.

High-value

• in-vitro diagnostic manufacturing
• GMP compliance
• validation and change management
• risk-based decision making
• data trending
• cross-site collaboration

Work setup

not specified; likely onsite or hybrid based on standard manufacturing roles.