Quality Engineer

Abbott Laboratories

Temecula (CA)

On-site

USD 61,000 - 123,000

Full time

8 days ago

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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 is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

Job Title

Quality Engineer

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to:

Career development with an international company where you can grow the career of which you dream.
Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
An excellent retirement savings plan with high employer contribution
Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

THE OPPORTUNITY

We currently have an opening for a Quality Engineer for the Vascular division. This role is located at our Temecula, CA location. This is a fully onsite role.

Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.

MAIN RESPONSIBILITIES

Provides hands-on quality engineering support for warehouse and distribution operations within a regulated medical device environment. This role ensures compliance with FDA Quality System Regulation (21 CFR Part 820), ISO 13485, and internal quality management system (QMS) requirements while driving continuous process improvements. The position works closely with Distribution Operations, Supply Chain, and Regulatory to support daily line activities, resolve quality issues, and improve operational effectiveness.

Provide in-person quality engineering support for distribution activities including receiving, material handling, labeling, storage, and distribution.
Perform timely investigation, containment, and disposition of nonconforming material in accordance with QMS procedures.
Support product holds, material and product reviews, and timely escalation of quality risks impacting product safety or compliance
Develops Process Monitoring Systems by identifying critical process steps applying methods to reduce process variation in order to reduce/eliminate the cause of defects.

Process Improvement and Risk Reduction

Lead and support continuous improvement initiatives to reduce distribution errors while maintaining regulatory compliance.
Apply root cause analysis methods (e.g., 5 Whys, Fishbone, 6Ms) and risk management tools (e.g., FMEA) to identify systemic causes and drive sustainable corrective actions.
Develop and implement error-proofing (poka-yoke) and process standardization improvements for material flow and handling.
Analyze quality metrics, audit findings, and deviations to identify trends and improvement opportunities.
Create and update risk analyses and FMEAs.
Lead project teams of moderate scope.

Compliance and Quality System Support

Ensure all processes comply with FDA QSR (21 CFR 820), ISO 13485, and applicable global regulatory requirements.
Write, review, and approve quality documentation including SOPs, work instructions, deviations, CAPAs, and training materials.
Support internal and regulatory audits; participate in audit readiness activities and corrective action follow-up as well as preventive action identification.
Ensure proper training and documentation are maintained for distribution personnel per QMS requirements
Execute stop shipments required for the division.

Cross-Functional/Cross-Site Collaboration

Partner with distribution Operations, Manufacturing Engineering, Supply Chain, Commercial Quality, and Regulatory Affairs on process changes and improvement initiatives.
Provide quality input and approval for changes related to equipment, material flow, labeling, and warehouse systems.
Support new product introductions, geography expansions, product changes, and product transfers impacting warehouse operations.
Provides support and guidance to less experienced staff; acts as a mentor to individual contributors, exercises influence over peer level and management; plans, organizes, and prioritizes own daily work routine to meet established schedule and exercises authority and judgment within defined limits to determine appropriate action.

EDUCATION AND EXPERIENCE YOU'LL BRING

Minimum Education

Bachelor's degree plus 2 years of related work experience with a good understanding of specified functional area, or Master's degree with 0-2 years of related work experience, or an equivalent combination of education and work experience.

Minimum Experience / Training

CAPA Process Experience
Working technical knowledge and application of concepts, practices and procedures. General understanding of business unit/group function.
Will perform this job in a quality system environment.
Failure to adequately perform tasks can result in noncompliance with governmental regulations.
Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors.
Exercises judgment within defined procedures and practices to determine appropriate action.
Has a broad knowledge of technical alternatives and an understanding of their impact on the systems environment.

Preferred Qualifications