Senior Quality Engineer - CAPA & Investigations Lead

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

Benefits offered by this job

Career development with international

Free HIP PPO medical coverage

High employer retirement contribution

Tuition reimbursement

FreeU education benefit

Diversity and inclusion accolades

Job summary

Abbott is seeking a Principal Quality Engineer to act as a liaison across R&D and Operations for investigations related to complaints, leading CAPA investigations and developing test methods to identify root causes. You will analyze data, develop process improvements, and guide compliance with quality regulations.

The role requires strong project management, ability to multi-task, and capability to drive cross-functional initiatives in a FDA/ISO-regulated environment.

Qualifications

• Minimum 5 years of Quality experience in a FDA/ISO regulated environment.
• Must be able to analyze data and interpret results.
• Strong project management and cross-functional leadership skills.

Responsibilities

• Implement and maintain the effectiveness of the quality system.
• Improve products/processes to better meet customer needs.
• Provide guidance on complaint investigation processes and ensure regulatory compliance.
• Set global standards for specifications and drawings identifying critical quality attributes.
• Capture complex technical requirements in policies and investigations.
• Translate business strategy into objectives and day-to-day activities.
• Lead complaint investigations as the technical expert with cross-functional liaison.
• Disseminate investigation results to SMEs and stakeholders.
• Structure studies to resolve cross-disciplinary issues and meet regulatory requirements.
• Lead and participate in team meetings, sharing resources and accountability.

Skills

Quality experience

CAPA investigations

Project management

Education

BS in Math, Science, or Engineering

Job description

Abbott is seeking a Principal Quality Engineer to act as a liaison across R&D and Operations for investigations related to complaints, leading CAPA investigations and developing test methods to identify root causes. You will analyze data, develop process improvements, and guide compliance with quality regulations.

The role requires strong project management, ability to multi-task, and capability to drive cross-functional initiatives in a FDA/ISO-regulated environment.