Process Quality Engineer: Accelerate Healthcare Excellence

Johnson & Johnson MedTech; Leeds; On-site; GBP 42,000 - 62,000; Full time

Job summary

Johnson & Johnson MedTech in Leeds is seeking a Process Quality Engineer to support quality improvement initiatives across the product lifecycle. You will drive process verification, validation, and compliance, partnering with R&D and cross‑functional teams to apply design controls and effective risk management.

The role requires a degree in engineering or related field and experience in manufacturing environments, with knowledge of FDA/ISO risk standards and Lean/Six Sigma tools.

Qualifications

• Degree in Engineering or related technical field is required.
• Experience in manufacturing or operations environments.
• Knowledge of product and process risk management in accordance with FDA and ISO standards.
• Experience with FDA and European regulatory environments preferred.
• Background in statistics, Lean, and Six Sigma methodologies including SPC, MSA, DOEs.

Responsibilities

• Supporting quality improvement initiatives, including process and product characterization.
• Supporting process verification and validation activities across the product lifecycle.
• Reviewing and analyzing the effectiveness of PDCA, Six Sigma, Kaizen, Lean techniques, and other improvement tools.
• Reviewing and analyzing product and process compliance with applicable standards and regulations, including QSRs and ISO 13485.
• Championing compliance with global regulations and standards (e.g., QSRs, ISO, EN, MDD) and supporting internal and external audits.
• Partnering with R&D and cross‑functional teams to ensure effective application of design controls, risk management, and investigation of design challenges.
• Supporting new product introductions as part of design transfer activities.
• Conducting investigations, documentation, review, and approval of non‑conformances, CAPAs, and customer complaints, including appropriate escalation of quality issues.
• Owning and monitoring quality metrics, including leading and lagging indicators.
• Collecting and analyzing data using statistical and analytical methods to support process improvements and day‑to‑day decision‑making.
• Developing, interpreting, and implementing standard and non‑standard sampling plans.
• Assessing the effectiveness of measurement tools, destructive and non‑destructive testing, and measurement system analyses.
• Evaluating risk mitigation strategies based on product classification, defect types, frequency, severity, patient risk, and process capability.
• Following all company guidelines related to Health, Safety, and Environmental practices.

Skills

Quality mindset

Data analysis

Problem-solving

Team collaboration

AI awareness

Education

Bachelor's degree in Engineering

Tools

SPC

MSA

DOE

Reliability tools

Statistical analysis

Job description

Johnson & Johnson MedTech in Leeds is seeking a Process Quality Engineer to support quality improvement initiatives across the product lifecycle. You will drive process verification, validation, and compliance, partnering with R&D and cross‑functional teams to apply design controls and effective risk management.

The role requires a degree in engineering or related field and experience in manufacturing environments, with knowledge of FDA/ISO risk standards and Lean/Six Sigma tools.