Principal Quality Engineer

Staff / Principal Quality Engineer

An innovative medical device company developing next-generation surgical technology is seeking a Staff / Principal Quality Engineer to ensure quality is built into products from concept through commercialization.

This role partners closely with Engineering, Manufacturing, Regulatory, and suppliers to support product development, design controls, risk management, manufacturing transfer, and regulatory compliance for Class II medical devices.

Key Responsibilities

• Drive Design Quality throughout product development and manufacturing
• Lead risk management activities, including DFMEA, PFMEA, and Design Controls
• Support product qualification, process validation, and manufacturing transfers
• Develop inspection methods, quality plans, and receiving inspection processes
• Partner with suppliers on qualifications, audits, and quality improvements
• Lead CAPA, NCR investigations, root cause analysis, and continuous improvement initiatives

Qualifications

• 5+ years of Quality Engineering experience within the medical device industry
• Strong knowledge of FDA Quality System Regulations, ISO 13485, and ISO 14971
• Experience with Design Controls, supplier quality, manufacturing transfer, and product development
• Experience supporting Class II electromechanical medical devices
• Familiarity with IEC 60601, IEC 62304, ISO 10993, and ISO 11135 is a plus
• Experience with PCB/PCBA assemblies, GD&T, statistical analysis, and process validation preferred