Senior Quality Engineer — IVD Process & CAPA Leader

Biopharma Careers; Pomona (CA); On-site; USD 100,000 - 140,000; Full time

Job summary

Abbott in Pomona, CA, is seeking a Senior Supplier Quality Engineer to lead quality engineering activities addressing product and process changes, complaints, and regulatory compliance. The role partners with operations for continuous improvement, supports design controls and lifecycle management for IVD devices, and drives CAPA effectiveness to ensure patient safety and product quality.

The position requires strong problem-solving, risk management, and cross-functional collaboration across R&D,

Qualifications

• Quality engineering activities addressing product/process changes and complaints.
• Engage in non-conformance, CAPA, and complaints processes.
• Support design controls, risk management, and lifecycle management for IVD devices.

Responsibilities

• Drive continuous process improvement with Operations to resolve issues.
• Develop, implement, and monitor CTQ measures to meet requirements.
• Administer enterprise software for complaint handling and investigations.
• Collaborate with R&D, Manufacturing, QC, Applications Support, and Design Engineering to address quality challenges.
• Lead multiple projects with coaching and mentorship to the team.

Skills

Process Improvement

CAPA

Root Cause Analysis

Risk Management

Quality Assurance

Cross-functional Collaboration

Regulatory Compliance

Tools

Enterprise Software

Job description

Abbott in Pomona, CA, is seeking a Senior Supplier Quality Engineer to lead quality engineering activities addressing product and process changes, complaints, and regulatory compliance. The role partners with operations for continuous improvement, supports design controls and lifecycle management for IVD devices, and drives CAPA effectiveness to ensure patient safety and product quality.

The position requires strong problem-solving, risk management, and cross-functional collaboration across R&D,