Process Quality Engineer: Six Sigma & Compliance

J&J Family of Companies; Leeds; On-site; GBP 42,000 - 62,000; Full time

Job summary

Johnson & Johnson is seeking a Quality Engineer to apply quality tools throughout the product lifecycle in a UK manufacturing setting. The role focuses on continuous improvement, process validation, and rigorous problem‑solving to prevent failures and ensure regulatory compliance.

You will partner with R&D and cross‑functional teams to apply design controls, manage risk, and support design transfer and new product introductions. A degree in engineering or a related field is preferred.

Qualifications

• A 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 per FDA/ISO standards.
• Experience in FDA and European regulatory environments preferred.

Responsibilities

• Support quality improvement initiatives and process/product characterization for continuous improvement and cost efficiency.
• Support process verification and validation across the product lifecycle.
• Review effectiveness of PDCA, Six Sigma, Kaizen, Lean techniques and other improvement tools.
• Review compliance with QSRs and ISO 13485 and other applicable standards.
• Champion compliance with global regulations and support audits.
• Partner with R&D and cross-functional teams on design controls, risk management, and design transfer.
• Support new product introductions as part of design transfer activities.
• Conduct investigations, documentation, review, and approval of non-conformances, CAPAs, and customer complaints.
• Own and monitor quality metrics, including leading and lagging indicators.
• Collect and analyze data using statistical methods to support decisions.
• Develop sampling plans and assess measurement systems (destructive and non-destructive).
• Evaluate risk mitigation strategies based on product classification and process capability.
• Follow company guidelines related to Health, Safety, and Environmental practices.

Skills

Problem-solving

Quality mindset

Statistical analysis

Lean Six Sigma

Risk management

Education

Engineering degree or related technical field

Tools

SPC

MSA

DoEs

Job description

Johnson & Johnson is seeking a Quality Engineer to apply quality tools throughout the product lifecycle in a UK manufacturing setting. The role focuses on continuous improvement, process validation, and rigorous problem‑solving to prevent failures and ensure regulatory compliance.

You will partner with R&D and cross‑functional teams to apply design controls, manage risk, and support design transfer and new product introductions. A degree in engineering or a related field is preferred.