Process Quality Engineer

Johnson & Johnson Innovative Medicine; Leeds; On-site; GBP 45,000 - 65,000; Full time

Job summary

Johnson & Johnson Innovative Medicine in Leeds seeks a Process Quality Engineer to support quality improvements across the product lifecycle.

In this role you will apply risk management, design controls, and cross‑functional collaboration to ensure compliance with QSRs, ISO 13485, and related standards while driving process optimization and robust CAPA management.

Qualifications

• Degree or equivalent in Engineering or a related technical field.
• Experience in manufacturing or operations environments.
• Knowledge of product and process risk management per FDA and ISO standards.
• Experience with risk mitigation strategies in FDA and EU contexts.
• Strong statistics, Lean and Six Sigma with SPC/MSA/DOE methods; awareness of AI concepts.

Responsibilities

• Support quality improvement initiatives and process characterization for cost efficiency.
• Support process verification and validation across the product lifecycle.
• Review PDCA, Six Sigma, Kaizen, Lean methods and their effectiveness.
• Ensure compliance with QSRs, ISO 13485 and related standards; support audits.
• Collaborate with R&D and cross‑functional teams on design controls and risk management.
• Assist with new product transfers and design transfer activities.
• Investigate non-conformances, CAPAs and customer complaints with proper escalation.
• Monitor quality metrics and lead/lag indicators; collect data for improvements.

Skills

Six Sigma

Lean methodologies

Statistics

AI concepts

Education

Engineering degree

Tools

SPC

MSA

DOE

Reliability tools

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function

Supply Chain Engineering

Job Sub Function

Quality Engineering

Job Category

Scientific/Technology

All Job Posting Locations

Leeds, West Yorkshire, United Kingdom

Job Description

We are searching for the best talent for Process Quality Engineer.

Purpose

The Quality Engineer applies Quality Engineering tools and practices to support the effective and efficient development, transfer, and maintenance of products and processes throughout the product lifecycle. In this role, we rely on your problem‑solving skills and quality mindset to improve processes aligned with our Quality and Business vision. The position applies appropriate risk management to prevent unanticipated failure modes, improve process capability, and support base business operations.

You will be responsible for

• Supporting quality improvement initiatives, including process and product characterization, that drive continuous improvement and cost efficiency
• 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

Qualifications / Requirements

• A minimum of a degree or equivalent experience, preferably in Engineering or a related technical field
• Experience working in manufacturing or operations environments
• Knowledge of product and process risk management in accordance with FDA and ISO standards
• Experience implementing appropriate risk mitigation strategies
• Experience working in both FDA and European regulatory environments is preferred
• Technical training or experience in Statistics, Lean, and Six Sigma methodologies, including SPC, MSA, DOEs, and reliability tools
• Demonstrated understanding of AI concepts and frameworks, including responsible and ethical AI practices, with experience using effective prompt generation to improve efficiency and productivity

We are committed to providing an inclusive and supportive work environment.

We offer competitive compensation and a comprehensive benefits package, along with opportunities for learning, development, and career growth. We are an equal opportunity employer and provide reasonable accommodations throughout the recruitment process.

Customer Centricity, Data Savvy, Document Management, Execution Focus, Good Automated Manufacturing Practice (GAMP), Issue Escalation, Lean Supply Chain Management, Process Control, Process Improvements, Quality Control Testing, Quality Services, Quality Standards, Quality Systems Documentation, Science, Technology, Engineering, and Math (STEM) Application, Supervision, Supply Planning, Technologically Savvy