Validation Engineer/Quality Systems Engineer

My client is a medical device company seeking a Validation Engineer to own the full validation lifecycle - from writing and executing protocols to maintaining the calibration system and supporting regulatory compliance. This role sits at the intersection of Quality Systems and engineering, and is central to the company's ability to bring compliant, high-quality products to market.

Why You Should Apply

• Broad scope - own validation, calibration, and quality systems work across the organization
• Direct impact on regulatory compliance for a growing medical device company
• Cross-functional visibility - partner with engineering, manufacturing, and quality leadership
• Salary range: $90,000 - $100,000
• Full benefits package including medical, dental, vision, and 401k

What You'll Be Doing

• Write, execute, and maintain validation protocols for manufacturing equipment, processes, and systems
• Manage the calibration system and equipment database
• Analyze validation data and identify nonconformities; recommend and track corrective actions
• Support design controls, CAPA, change control, and post-market surveillance activities
• Review DHF deliverables and provide FDA compliance guidance

About You

• Be able to do the job as described
• Knowledge of ISO 13485, ISO 14971, 21 CFR Part 820, and EU-MDR
• Experience with process and test method validations in an FDA-regulated industry
• Background in medical device or pharmaceutical manufacturing
• Blow-Fill-Seal experience is a plus

This is a full-time, permanent direct-hire opportunity. My client is unable to provide visa sponsorship now or in the future. Applicants must be authorized to work in the United States without sponsorship.

How To Apply

We'd love to see your resume, but we don't need it to have a conversation. Email Cat at View email address on click.appcast.io and tell me why you're interested. Or, if you do have a resume ready, apply here.