Senior Supplier Quality Engineer - Complaint Handling CAPA

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

Job summary

Abbott, a global healthcare leader, seeks a Senior Supplier Quality Engineer (Complaint Handling) at the Pomona, CA site. You will drive complaint handling, CAPA, and risk management with cross-functional teams to ensure product quality and regulatory compliance.

In this role, you’ll collaborate with R&D, Manufacturing, and QA to address nonconformances, lead process improvements, and support audits under QMS, FDA, and ISO standards. A strong quality background in biotech is essential.

Qualifications

• Bachelor’s degree in science or engineering and at least 5 years in biotech quality.
• 3–5 years of progressive responsibility in quality roles.

Responsibilities

• Drive continuous process improvement with Operations to enhance processes and resolve issues.
• Develop and monitor process control systems and CTQ measures to meet requirements.
• Administer complaint handling; investigate inquiries and adhere to regulatory reporting.
• Provide QA support for IVD medical device development and lifecycle management.
• Support risk management activities including FMEA and risk assessments.
• Investigate and resolve nonconformances using CAPA and root cause analysis.
• Collaborate with R&D, Manufacturing, QC, Applications Support and Design Engineering.
• Lead multiple projects, providing mentorship and cross-functional leadership.
• Ensure compliance with QMS, ISO, FDA, and GMP standards; support audits and validation.

Skills

Quality engineering

Process improvement

CAPA

Regulatory compliance

Root cause analysis

Leadership

Cross-functional leadership

Project management

Education

Bachelor's degree in science/engineering

Tools

QMS software

CAPA systems

Job description

Abbott, a global healthcare leader, seeks a Senior Supplier Quality Engineer (Complaint Handling) at the Pomona, CA site. You will drive complaint handling, CAPA, and risk management with cross-functional teams to ensure product quality and regulatory compliance.

In this role, you’ll collaborate with R&D, Manufacturing, and QA to address nonconformances, lead process improvements, and support audits under QMS, FDA, and ISO standards. A strong quality background in biotech is essential.