Onsite Quality Engineer – Distribution & Process Improvement

Abbott Laboratories; Temecula (CA); On-site; USD 61,000 - 123,000; Full time

Benefits offered by this job

Free medical coverage

Strong retirement plan

Tuition reimbursement

Education benefit

Job summary

Abbott Laboratories in Temecula, CA is seeking a Quality Engineer to support warehouse and distribution activities within a regulated medical device environment, ensuring compliance with FDA QSR and ISO 13485 while driving process improvements.

You will collaborate with Distribution Operations, Supply Chain and Regulatory, perform investigations of nonconforming material, support CAPAs and risk analyses, and help implement error-proofing and quality systems to protect product quality and patient

Qualifications

• Bachelor's degree plus 2 years of related work experience, or Master's with 0-2 years of related work experience.
• CAPA process experience.
• Working in a quality system environment.
• Ability to analyze problems of moderate scope and identify factors.

Responsibilities

• Provide hands-on quality engineering support for warehouse and distribution in a regulated medical device environment.
• Ensure compliance with FDA QSR (21 CFR 820), ISO 13485, and QMS requirements; drive continuous improvements.
• Lead investigations, containment, and disposition of nonconforming material per QMS procedures.
• Develop and implement risk analyses and CAPAs; apply root cause analysis methods; support stop shipments when required.

Skills

Quality Engineering

FDA QSR

ISO 13485

CAPA

FMEA

Root Cause Analysis

Education

Bachelor's degree

Master's degree

Job description

Abbott Laboratories in Temecula, CA is seeking a Quality Engineer to support warehouse and distribution activities within a regulated medical device environment, ensuring compliance with FDA QSR and ISO 13485 while driving process improvements.

You will collaborate with Distribution Operations, Supply Chain and Regulatory, perform investigations of nonconforming material, support CAPAs and risk analyses, and help implement error-proofing and quality systems to protect product quality and patient