Manufacturing Quality Engineer I - Drive Quality & Compliance

Illumina; San Diego (CA); On-site; USD 63,000 - 94,000; Full time

Benefits offered by this job

Health/dental/vision benefits

Retirement benefits

Paid time off

Job summary

Illumina in San Diego, CA is seeking a Manufacturing and Ops Quality Engineer I to support day-to-day sustaining activities within a regulated manufacturing environment. You will interact with Manufacturing and Process Engineering to drive validation, non-conformances, and change orders, ensuring GMP and ISO compliance.

With a Bachelor's in Engineering or Science and 0–2 years in QA, you will contribute to risk-based decisions, CAPA investigations, and data-driven improvements across the product

Qualifications

• Bachelor's degree in Engineering and/or Science required.
• 0–2 years experience in quality assurance in a regulated environment preferred.
• Knowledge of 21 CFR 820, ISO 13485, ISO 14971, IVDD is a plus.

Responsibilities

• Provide ongoing quality engineering support throughout the product life cycle.
• Support validation planning and transfer activities with engineering/manufacturing.
• Ensure adequacy of non-conformances and CAPA records and investigations.
• Review verification/validation reports for GMP compliance and close gaps.
• Collaborate with cross-functional teams to meet FDA/ISO requirements.
• Trend, analyze, and report quality data to improve products and processes.

Skills

Quality engineering

Regulatory compliance

Cross-functional collaboration

Communication

Project management

Education

Bachelor's degree in Engineering or Science

Tools

SAP

ERP systems

Job description

Illumina in San Diego, CA is seeking a Manufacturing and Ops Quality Engineer I to support day-to-day sustaining activities within a regulated manufacturing environment. You will interact with Manufacturing and Process Engineering to drive validation, non-conformances, and change orders, ensuring GMP and ISO compliance.

With a Bachelor's in Engineering or Science and 0–2 years in QA, you will contribute to risk-based decisions, CAPA investigations, and data-driven improvements across the product