Senior Supplier Quality Engineer – IVD/Medical Devices

Abbott; Pomona (CA); On-site; USD 90,000 - 180,000; Full time

Job summary

Abbott in Pomona, CA, seeks a Senior Supplier Quality Engineer to lead quality engineering activities addressing product and process changes, complaints, and compliance. You will partner with Operations for process improvement and support design control activities for new products.

Responsibilities include implementing CTQ measures, leading CAPA investigations, and ensuring adherence to QMS, ISO, FDA standards. Strong project leadership and cross-functional collaboration are essential.

Qualifications

• Bachelor's degree in science or engineering.
• 5 years in a quality role in biotech with 3–5 years progressive positions.
• ASQ CQE or other certifications preferred.
• Experience in IVD/medical devices or regulated manufacturing environments.

Responsibilities

• Drive continuous process improvements with Operations to resolve issues.
• Monitor CTQ measures to ensure regulatory and customer requirements.
• Administer complaint handling and regulatory reporting in enterprise systems.
• Support design controls, risk management, quality planning, verification/validation, and change control.
• Lead cross-functional teams to address quality challenges and drive improvements.

Skills

Project leadership

Quality improvement

Root cause analysis

CAPA

Education

Bachelor's degree in sciences/engineering

Job description

Abbott in Pomona, CA, seeks a Senior Supplier Quality Engineer to lead quality engineering activities addressing product and process changes, complaints, and compliance. You will partner with Operations for process improvement and support design control activities for new products.

Responsibilities include implementing CTQ measures, leading CAPA investigations, and ensuring adherence to QMS, ISO, FDA standards. Strong project leadership and cross-functional collaboration are essential.