Sr Validation Quality Engineer

Overview

Senior Validation Quality Engineer role focused on ensuring the integrity, compliance, and performance of electromechanical medical devices. This position sits at the intersection of quality, engineering, and manufacturing, driving validation excellence that impacts patient safety, regulatory confidence, and operational reliability across multiple facilities.

• Influence validation strategy across manufacturing sites and contract manufacturers
• Be a quality leader in a highly regulated medical device environment
• Collaborate with engineering, R&D, suppliers, and quality leadership
• Hybrid work model with strong onsite collaboration
• Competitive salary and unmatched bonuses
• Amazing benefits and time off package

• Lead product, process, test method, and equipment validation and re-validation activities
• Oversee IQ/OQ/PQ activities, including computerized systems
• Support new product introductions and process development initiatives
• Review and approve SOPs, specifications, and validation documentation
• Drive NCR, CAPA, scrap, and rework analysis for continuous improvement
• Support regulatory inspections and internal/supplier audits
• Partner with suppliers on quality changes and issue resolution

• BS in Engineering or a Physical Science (or equivalent experience)
• Deep knowledge of medical device or pharmaceutical quality systems
• Strong validation, statistical analysis, and technical writing expertise
• Hands-on experience with ISO 13485, FDA QSR, GMPs
• Confident communicator able to lead with minimal supervision

We’d love to see your resume, but we don’t need it to have a conversation. Send us an email to and tell us why you’re interested. Or, feel free to email your resume. Please include Job#19715
.