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CAPA Quality Engineer
Job in
Fall River, Bristol County, Massachusetts, 02720, USA
Listed on 2026-06-04
Listing for:
United Pharma
Full Time
position Listed on 2026-06-04
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering -
Engineering
Quality Engineering, Process Engineer
Job Description & How to Apply Below
We are seeking an experienced CAPA Quality Engineer to support complex CAPA investigations, root cause analysis, and quality system improvement activities within a regulated medical device environment. This role will focus on driving CAPA activities from initiation through closure while partnering cross-functionally to ensure compliance and effective corrective actions.
Responsibilities- Lead CAPA investigations, root cause analysis, and corrective actions
- Manage CAPA timelines, meetings, and cross-functional coordination
- Analyze quality data and identify non-conformance trends
- Support audit readiness and present CAPAs during review board meetings
- Apply statistical and problem-solving tools to support investigations
- Ensure compliance with FDA regulations and ISO standards
- Support continuous improvement of quality systems and CAPA processes
- Bachelor’s degree in Engineering or related discipline
- 5+ years of CAPA / Quality Engineering experience
- Strong knowledge of FDA, ISO 13485, ISO 14971 & quality regulations
- Experience with root cause analysis and quality problem-solving tools
- Strong project management and communication skills
- Medical device or regulated industry experience required
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