Validation Engineer
Listed on 2026-06-03
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Engineering
Quality Engineering, Regulatory Compliance Specialist -
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist
Role
Validation Engineer — Boston, MA
OverviewThis engagement supports a large-scale Quality Management System (QMS) remediation for a medical device organization under FDA oversight. The initiative focuses on closing gaps and driving compliance with 21 CFR Part 820 and ISO 13485 across key quality areas including validation, CAPA, complaints, and design controls. The program is audit-driven and requires strong onsite execution, with an emphasis on documentation remediation, inspection readiness, and sustainable compliance improvements.
PositionSummary
Seeking Validation Engineers (Associate through Senior level) to support execution-heavy validation remediation activities. This is a hands-on role focused on closing validation gaps and remediating documentation in a regulated manufacturing environment.
Responsibilities- Execute and remediate validation activities (IQ/OQ/PQ, process validation)
- Identify and close compliance gaps against FDA and ISO requirements
- Update and remediate legacy validation documentation
- Author protocols, reports, and summary documentation
- Partner with Quality, Manufacturing, and Engineering teams
- Support audit readiness and inspection activities
- 3 5 years experience in validation, quality, or manufacturing.
- Strong hands-on experience executing and authoring IQ/OQ/PQ
- Deep knowledge of 21 CFR Part 820 and ISO 13485
- Experience with remediation or audit-driven programs
- Exposure to regulated environments (medical device preferred)
- Experience supporting validation execution or documentation
- Strong attention to detail
- FDA inspection, warning letter, or remediation experience
- CSV / Part 11 exposure
- Experience with high-volume documentation remediation
Contact:
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