Quality Engineer
Abbott · Temecula, CA
QualityFull-time$61k–$123kCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Abbott seeks a Quality Engineer for its Vascular division in Temecula, California to provide hands-on quality engineering support for warehouse and distribution operations. The role ensures FDA and ISO compliance while driving continuous process improvements and resolving quality issues in a regulated medical device environment.
What they're looking for
- Bachelor's degree plus 2 years related work experience, or Master's degree with 0-2 years experience
- CAPA process experience and working knowledge of quality system procedures
- Understanding of FDA Quality System Regulation (21 CFR Part 820) and ISO 13485 requirements
- Experience with root cause analysis methods and risk management tools (FMEA, 5 Whys, Fishbone)
- Demonstrated ability to lead process improvement initiatives and cross-functional projects
- Strong written and verbal communication for documentation, training, and audit support
What you'll be doing
- Provide in-person quality engineering support for receiving, material handling, labeling, storage, and distribution activities
- Investigate nonconforming material, support product holds, and escalate quality risks affecting product safety or compliance
- Lead continuous improvement initiatives using root cause analysis and error-proofing methods to reduce distribution errors
- Write, review, and approve quality documentation including SOPs, deviations, CAPAs, and training materials
- Partner with operations, supply chain, and regulatory teams on process changes and new product introductions
Privacy & handoff
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