JOB DESCRIPTION:Job TitleQuality Engineer
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
- Project Management Experience, a plus
- Line Support Experience, a plus
Apply NowLearn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.
The base pay for this position is $61,300.00 - $122,700.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Operations Quality
DIVISION:AVD Vascular
LOCATION:United States > Temecula : AWDC
ADDITIONAL LOCATIONS:WORK SHIFT:Standard
TRAVEL:Yes, 10 % of the Time
MEDICAL SURVEILLANCE:No
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
