Quality Engineer (medical Devices)

Description:

Fusion Life Sciences is seeking a Quality Engineer with strong manufacturing, process validation (IQ/OQ/PQ), and CAPA experience to support a regulated medical device environment.

What you’ll do
• Lead/execute process validation activities (IQ/OQ/PQ) to meet FDA/ISO/GMP
• Drive CAPA investigations, RCA, and implementation of corrective/preventive actions
• Author/review validation protocols, reports, and quality records
• Partner with Manufacturing, R&D, and Quality to resolve issues and improve yield
• Ensure compliance with FDA, ISO 13485, and GMP
• Support internal/external audits and continuous improvement initiatives

You bring
• Experience in medical device manufacturing quality
• Hands-on IQ/OQ/PQ validation and CAPA/RCA
• Strong documentation and cross-functional collaboration skills

Please include resume, location, W2 rate, work auth, start availability, interview windows, and two supervisory refs