Manufacturing Quality Engineer: Medical Devices & Compliance

GE HealthCare; Uppsala kommun; On-site; SEK 550,000 - 750,000; Full time

Benefits offered by this job

Professional development opportunities

Exposure to advanced manufacturing teh

Collaboration with experienced pros

Job summary

GE HealthCare in Uppsala seeks a Manufacturing Quality Engineer to lead quality and process improvements across manufacturing operations. You will drive CAPAs, validations, and regulatory compliance while supporting NPI and process transfers.

The role emphasizes collaboration with production, quality, and regulatory teams to ensure safe, compliant, and efficient manufacturing. The successful candidate will lead investigations, support audits, and promote a robust safety and environmental culture

Qualifications

• Bachelor's degree or equivalent in a relevant engineering/technical discipline.
• Experience in manufacturing, quality engineering, process engineering, or related technical field.
• Strong analytical and problem-solving skills with the ability to priortize multiple activities.
• Experience in regulated industries and structured quality systems.
• Excellent communication and collaboration skills.
• Proven ability to work effectively within cross-functional and international teams.
• Knowledge of manufacturing processes, root cause analysis, risk management, and continuous improvement methodologies.

Responsibilities

• Drive continuous improvement initiatives focused on product quality, process performance, productivity, and cost efficiency.
• Identify manufacturing challenges, perform root cause analysis, and implement corrective and preventive actions.
• Provide daily technical support to production teams regarding methods, tooling, equipment, and processes.
• Support new product introductions, design transfers, process validation, and manufacturing readiness activities.
• Lead Lean Manufacturing initiatives to improve flow, efficiency, and operational excellence.
• Lead and support investigations related to non-conformances, complaints, CAPAs, and quality events.
• Plan, perform, and support internal quality audits; participate in external inspections and audits.
• Ensure compliance with ISO 13485, FDA, and internal procedures.

Skills

Analytical skills

Problem solving

Cross-functional collaboration

Root cause analysis

Risk management

Continuous improvement

International teamwork

Communication skills

Education

Bachelor's degree in Mechanical Engineering, Industrial Engineering, Manufacturing Engineering, Quality Engineering, Electrical Engineering, or related technical discipline

Job description

GE HealthCare in Uppsala seeks a Manufacturing Quality Engineer to lead quality and process improvements across manufacturing operations. You will drive CAPAs, validations, and regulatory compliance while supporting NPI and process transfers.

The role emphasizes collaboration with production, quality, and regulatory teams to ensure safe, compliant, and efficient manufacturing. The successful candidate will lead investigations, support audits, and promote a robust safety and environmental culture