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CAPA Quality Engineer

Job

Kappium LLC

Cambridge, MA (In Person)

Full-Time

Posted 4 days ago (Updated 1 day ago) • Actively hiring

Expires 7/4/2026

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Job Description

CAPA QUALITY ENGINEER
Position Overview:
This position is crucial for supporting the injunction lift and ensuring the CAPA program is in a healthy state. The CAPA Quality Engineer will be responsible for leading CAPA engineering activities, conducting complex investigations, root cause analysis, and quality problem-solving.
Job Responsibilities:
Facilitate product and process Corrective and Preventive Action (CAPA) investigations from issue identification through implementation of solutions and effectiveness monitoring. Project manage all aspects of CAPA activity, including scheduling meetings and ensuring deliverables are met within project timelines. Represent CAPAs during audits and CAPA Review Board meetings. Lead and mentor cross-functional teams in implementing root cause analysis techniques. Analyze quality monitoring data sources and apply statistical techniques to identify causes of non-conformances. Work with management to ensure CAPA action plans are supported and necessary resources are available. Independently produce and complete CAPA records. Perform timely CAPA engineering tasks such as assessing issue descriptions, reviewing data sources, and assisting with root cause analysis.
Requirements:
Bachelor''s degree in engineering with 7+ years of related experience (strong Med Device experience) or Master''s degree with 5+ years of related experience. Ability to understand and analyze complex problems in software and hardware design. Demonstrated knowledge of root cause analysis tools and techniques. Strong understanding of global regulations such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 9001, and
ISO 14971.
Excellent project management skills to manage all CAPA activities effectively. Ability to analyze data and apply statistical techniques.
Additional Information:
Location:
Murrysville, PA or Cambridge, MA (Onsite)
Duration:
6-month assignment
Skills:
CAPA Proficiency in MS Teams Submission requires last 4 digits of SS# and DOB