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Senior Quality Systems & CAPA Engineer; ISO , FDA

Job in Pleasanton, Atascosa County, Texas, 78064, USA
Listing for: Dormont Manufacturing Co
Full Time position
Listed on 2026-07-23
Job specializations:
  • Quality Assurance - QA/QC
    Quality Engineering, Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 90000 - 180000 USD Yearly USD 90000.00 180000.00 YEAR
Job Description & How to Apply Below
Position: Senior Quality Systems & CAPA Engineer (ISO 13485, FDA)

Abbott in Pleasanton, CA seeks a Senior Quality Systems Engineer to ensure product conformance with quality standards and ISO/FDA requirements. You’ll collaborate with cross-functional teams to strengthen the quality system, drive metrics, and support CAPA initiatives.

The role focuses on improving quality infrastructure, performance metrics, and compliance with US 21 CFR 820, ISO 13485, and related standards. Strong data analysis and audit participation are essential.

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Position Requirements
10+ Years work experience
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