Principal Quality Engineer: CAPA & Investigations Lead

Abbott; United States; On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Free medical coverage

High-contribution retirement plan

Tuition reimbursement

FreeU education benefit

Job summary

Abbott is seeking a Principal Quality Engineer to serve as the technical lead on large CAPA investigations, liaise with R&D, Operations and other Quality functions, and develop robust test methods to identify root and potential causes of complaints.

The role requires implementing and maintaining the quality system, translating business strategy into concrete objectives, guiding cross‑functional teams, and ensuring investigations are compliant with FDA/ISO regulations while driving continuous

Qualifications

• BS in Math, Science, or Engineering 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.
• Proactively address complaints and drive product/process improvements to meet customer needs.
• Provide guidance on complaint investigation processes and ensure regulatory compliance.
• Set global standards for specifications and drawings highlighting critical quality attributes.
• Capture complex technical requirements in policies, design plans, and investigations.
• Translate business strategy into objectives and daily actions.
• Lead cross‑functional investigations and disseminate results to SMEs.

Skills

Quality assurance

CAPA investigations

Regulatory compliance

Project management

Education

BS in Math, Science, or Engineering

Job description

Abbott is seeking a Principal Quality Engineer to serve as the technical lead on large CAPA investigations, liaise with R&D, Operations and other Quality functions, and develop robust test methods to identify root and potential causes of complaints.

The role requires implementing and maintaining the quality system, translating business strategy into concrete objectives, guiding cross‑functional teams, and ensuring investigations are compliant with FDA/ISO regulations while driving continuous