Manufacturing Quality Engineer

About the role

GE Healthcare is looking for a Manufacturing Quality Engineer to join its Supply Chain organization in Uppsala. The role combines manufacturing engineering, quality engineering, compliance and continuous improvement in a regulated medical technology environment. The engineer provides technical leadership to production teams, drives quality and process improvements, ensures regulatory compliance and supports the introduction and sustainment of manufacturing processes, equipment and products.

Key responsibilities

• Drive continuous improvement of product quality, process performance, productivity and cost efficiency, and lead root cause analysis and corrective and preventive actions
• Support new product introductions, design transfers, process validation, equipment implementation and manufacturing readiness
• Act as the Quality Engineering representative at the Uppsala site and lead investigations of non-conformances, complaints, CAPAs and quality events
• Take part in site CAPA Board activities and ensure compliance with ISO 13485, FDA and internal quality systems
• Plan and run internal quality audits and support external inspections by regulators, notified bodies and customers
• Lead validation and verification of processes, equipment, software and tooling, including validation plans and protocols
• Promote a safety culture and ensure compliance with environmental, health and safety requirements
• Follow the Quality Management System, complete quality and compliance training and stay up to date on document control, design transfer, verification and validation, DMRs, DHRs and electronic records

Required profile

• Bachelor's degree in Mechanical, Industrial, Manufacturing, Quality, Electrical Engineering or a related technical discipline
• Experience in manufacturing, quality engineering, process engineering or a related technical field
• Experience in regulated industries and structured quality systems
• Strong analytical and problem-solving skills, and proven ability to work in cross-functional and international teams
• Preferred: master's degree, experience in medical devices, pharma, biotech or other regulated industries, and knowledge of ISO 13485, FDA QSR and GMP

Required skills

• Root cause analysis and risk management
• Continuous improvement methodologies (Lean, Six Sigma preferred)
• CAPA investigations and validation activities

What we offer

• A highly visible role with significant influence on manufacturing quality and operational performance
• Opportunities to lead strategic quality and process improvement initiatives
• Exposure to advanced manufacturing technologies in a regulated medical technology environment
• Collaboration with experienced engineering, quality, operations and regulatory professionals
• A culture focused on innovation, continuous improvement, patient impact and professional development