Senior Quality Engineer: CAPA & Investigations Lead

Regulatory Jobs; Alameda (CA); On-site; USD 114,000 - 228,000; Full time

Benefits offered by this job

Career development

HIP PPO medical coverage

Strong retirement plan with high match

Tuition reimbursement and FreeU degree

Job summary

Abbott in Alameda, CA is seeking a Principal Quality Engineer to lead CAPA investigations and drive product improvements across R&D and Operations. You will analyze data, set investigation standards, and act as technical lead on complex investigations while collaborating with global Quality and cross-functional teams.

The role requires at least 5 years of FDA/ISO regulated quality experience and a BS in a science or engineering discipline.

Qualifications

• BS in Math, Science, or Engineering disciplines preferred, or equivalent combination of education and work experience will be considered.
• Minimum 5 years of Quality experience in a FDA/ISO regulated environment.

Responsibilities

• Implement and maintain the quality system effectively.
• Lead CAPA investigations and provide root cause analysis.
• Coordinate with R&D, Operations, and other Quality functions.
• Set global standards for specifications and drawings that identify critical quality attributes.
• Guide complaint investigations and ensure regulatory compliance.
• Manage projects and prioritize tasks to meet business objectives.

Skills

Quality engineering

CAPA investigations

Data analysis

Cross-functional collaboration

Education

BS in Math/Science/Engineering

Job description

Abbott in Alameda, CA is seeking a Principal Quality Engineer to lead CAPA investigations and drive product improvements across R&D and Operations. You will analyze data, set investigation standards, and act as technical lead on complex investigations while collaborating with global Quality and cross-functional teams.

The role requires at least 5 years of FDA/ISO regulated quality experience and a BS in a science or engineering discipline.