Validation Engineer; Medical Device

Overview

Duration: 18+ Months (Potential Extension)

We are seeking experienced Validation Engineers to support a large-scale Quality Management System (QMS) remediation initiative for a leading medical device manufacturing organization operating under FDA oversight. This project is focused on strengthening compliance and closing gaps related to 21 CFR Part 820 and ISO 13485 across critical quality systems including validation, CAPA, complaints, and design controls.

This is a highly execution-focused role requiring strong hands-on validation experience in regulated manufacturing environments. The ideal candidate will support remediation activities, documentation updates, audit readiness, and sustainable quality improvements.

• Execute and remediate validation activities including IQ, OQ, PQ, and process validation
• Identify and close compliance gaps in alignment with FDA and ISO standards
• Review, update, and remediate legacy validation documentation
• Author and revise validation protocols, reports, and summary documentation
• Collaborate cross-functionally with Quality, Manufacturing, and Engineering teams
• Support inspection readiness and audit-related activities
• Ensure validation deliverables meet regulatory and internal quality requirements
• Assist with continuous improvement initiatives related to validation and compliance processes

• 3–5 years of experience in validation, quality, or manufacturing within regulated industries
• Strong hands-on experience executing and authoring IQ/OQ/PQ documentation
• Solid understanding of 21 CFR Part 820 and ISO 13485 requirements
• Experience supporting remediation or audit-driven quality programs
• Background working in regulated manufacturing environments (medical device preferred)
• Experience supporting validation execution and documentation remediation activities
• Strong attention to detail and documentation accuracy
• Excellent communication and cross-functional collaboration skills

• Experience supporting FDA inspections, warning letter remediation, or compliance initiatives
• Exposure to CSV and 21 CFR Part 11 requirements
• Experience handling high-volume documentation remediation projects
• Prior experience within medical device manufacturing environments preferred

• This role requires consistent onsite support in Boston, MA
• Travel expenses for onsite work will be reimbursed
• Opportunity to contribute to a high-visibility compliance and remediation program within the medical device industry