Quality Engineer

A growing medical device manufacturer is looking to add a Quality Engineer to support ongoing product development and manufacturing quality activities within a Class II/III regulated environment.

This position will work cross-functionally with Manufacturing, R&D, Supplier Quality, and Regulatory teams to drive quality improvements, support compliance activities, and help ensure products meet both internal and external standards.

• Support and maintain the Quality Management System (QMS) in compliance with FDA and ISO 13485 requirements
• Lead and support CAPA investigations, root cause analysis, and corrective actions
• Participate in NCR, deviation, and complaint investigations
• Support manufacturing and process validation activities (IQ/OQ/PQ)
• Partner with Engineering teams on design changes, risk assessments, and product transfers
• Support supplier quality activities including qualification and performance monitoring
• Assist with internal and external audits, including FDA and notified body inspections
• Drive continuous improvement initiatives across manufacturing and quality systems
• Review and approve quality documentation, protocols, and reports

• Bachelor’s degree in Engineering or related technical field
• 3-8+ years of Quality Engineering experience within medical devices or another regulated industry
• Strong understanding of FDA QSR, ISO 13485, CAPA, NCR, and validation activities
• Experience supporting manufacturing and/or product development environments
• Familiarity with risk management methodologies and root cause analysis tools
• Strong communication and cross-functional collaboration skills

• Experience with Class III or implantable medical devices
• Exposure to spinal, orthopedic, or other complex device systems
• ASQ certification (CQE) preferred
• Experience in fast-paced growth environments

This is an opportunity to join a collaborative and technically driven organization developing innovative medical technologies with strong long-term growth potential.