Manufacturing Quality Engineering

Job Description Summary We are seeking a highly motivated Manufacturing Quality Engineer to join our Supply Chain organization in Uppsala. This is a key role combining manufacturing engineering, quality engineering, compliance, and continuous improvement responsibilities within a regulated medical technology environment.

The successful candidate will provide technical leadership to production teams, drive quality and process improvements, ensure regulatory compliance, and support the successful introduction and sustainment of manufacturing processes, equipment, and products. The role offers broad exposure across manufacturing, quality assurance, validation, audits, CAPA management.

This position is ideal for an engineer who enjoys solving complex problems, driving improvements, leading quality initiatives, and collaborating across functions to deliver safe, compliant, and efficient manufacturing operations.

Job Description Key Responsibilities Manufacturing & Process Improvement

• Drive continuous improvement initiatives focused on product quality, process performance, productivity, and cost efficiency.
• Identify manufacturing challenges, perform root cause analysis, and implement sustainable corrective and preventive actions.
• Provide daily technical support to production teams regarding manufacturing methods, tooling, equipment, processes, and product-related issues.
• Support new product introductions (NPI), design transfers, process validation, equipment implementation, and manufacturing readiness activities.
• Lead and support Lean Manufacturing initiatives to improve flow, efficiency, and operational excellence.

Quality & Compliance Leadership

• Serve as the Quality Engineering representative within the Supply Chain organization at the Uppsala site.
• Lead and support investigations related to non-conformances, complaints, CAPAs, and quality events.
• Participate in and support site CAPA Board activities, ensuring timely and effective closure of investigations and actions.
• Maintain compliance with applicable quality systems, regulatory requirements, and industry standards, including ISO 13485, FDA, and internal procedures.

Audits & Regulatory Support

• Plan, perform, and support internal quality audits.
• Actively participate in external inspections and audits conducted by regulatory authorities, notified bodies, and customers.
• Ensure effective responses to audit observations and support implementation of corrective actions.

Validation & Equipment Management

• Lead and support validation and verification activities for manufacturing processes, equipment, software, and tooling.
• Develop validation plans, execute protocols, analyze data, and document results.

Safety & Environmental Leadership

• Promote and support a strong safety culture within manufacturing operations.
• Ensure processes, equipment, and work methods comply with environmental, health, and safety requirements.
• Identify workplace risks and drive corrective actions to maintain a safe and compliant working environment.

Quality Responsibilities

• Comply with the GE HealthCare Quality Management System, Quality Policy, and applicable regulatory requirements.

• Complete assigned Quality and Compliance training within established timelines.

• Identify, escalate, and address quality and compliance concerns in a timely manner.

• Maintain knowledge of and compliance with requirements related to:

• Document Control

• Design Transfer

• Verification & Validation

• Acceptance Activities

• Device Master Records (DMR)

• Device History Records (DHR)

• Electronic Records and Electronic Signatures

Required Qualifications

• Bachelor's degree in Mechanical Engineering, Industrial Engineering, Manufacturing Engineering, Quality Engineering, Electrical Engineering, or related technical discipline.
• Experience in manufacturing, quality engineering, process engineering, or a related technical field.
• Strong analytical and problem-solving skills with the ability to effectively prioritize and manage multiple activities.
• Experience working within 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.

Preferred Qualifications

• Master's degree in Engineering, Quality, Manufacturing, or Business.
• Experience within medical device, pharmaceutical, biotechnology, or other regulated industries.
• Working knowledge of ISO 13485, FDA Quality System Regulations, and GMP requirements.
• Experience in, CAPA investigations, validation activities, and quality improvement projects.
• Certification or experience in Lean, Six Sigma, or continuous improvement methodologies.
• Demonstrated success in identifying and implementing best practices.
• Experience working in matrix organizations and managing ambiguity.
• Previous project management or project leadership experience.

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.

Additional Information Relocation Assistance Provided: No