Process Quality Engineer (MedTech)

Location: Leeds, West Yorkshire, United Kingdom; onsite

Company

Johnson & Johnson MedTech develops healthcare and medical technology solutions across the product lifecycle.

What you will do

• Support quality improvement initiatives, product and process characterization, and continuous improvement programs.
• Support process verification, validation, new product introductions, and design transfer activities.
• Apply risk management, design controls, and regulatory standards including QSRs, ISO 13485, ISO, EN, and MDD.
• Investigate and document non-conformances, CAPAs, and customer complaints, escalating quality issues when appropriate.
• Own and monitor quality metrics and analyze data to support process improvements and operational decisions.
• Develop sampling plans and assess measurement tools, testing methods, measurement systems, and risk mitigation strategies.

Requirements

• Degree or equivalent experience, preferably in engineering or a related technical field.
• Experience in manufacturing or operations environments.
• Knowledge of product and process risk management aligned with FDA and ISO standards.
• Experience implementing risk mitigation strategies and supporting audits.
• Training or experience in statistics, Lean, and Six Sigma, including SPC, MSA, DOE, and reliability tools.
• Understanding of AI concepts, frameworks, responsible and ethical AI practices, and prompt generation.

Nice to have

• Experience working in both FDA and European regulatory environments.
• Knowledge of GAMP, process control, quality systems documentation, and automated manufacturing practices.

Culture & Benefits

• Inclusive and supportive work environment.
• Competitive compensation and comprehensive benefits package.
• Learning, development, and career growth opportunities.
• Reasonable accommodations throughout the recruitment process.