Senior Process Quality Engineer

Johnson & Johnson; Leeds; On-site; GBP 40,000 - 55,000; Full time

Job summary

A leading healthcare company is seeking a Process Quality Engineer in Leeds to enhance quality processes and compliance within their innovative Orthopaedics division. You will engage in risk management, support quality initiatives, and be involved in product lifecycles. Ideal candidates should possess an engineering degree and experience in FDA and European regulatory environments. You will also work closely with cross-functional teams to drive product introduction and improve process capability. This full-time position offers a pivotal role in shaping patient-centered outcomes.

Benefits

Health, Safety, and Environmental practices

Opportunity to work with cutting-edge technology

Qualifications

• A minimum of a Degree or equivalent, preferably in Engineering and/or related technical field.
• Experience working in both an FDA and European regulatory environment is preferred.
• Knowledge of product/process Risk Management (FDA and ISO standards) is required.

Responsibilities

• Support quality improvement initiatives such as process and product characterizations.
• Champion compliance to Global Regulations and standards including audit support.
• Conduct investigation and approval of non-conformances, CAPAs, and customer complaints.

Skills

Statistical software packages

Hands-on troubleshooting

Understanding of manufacturing equipment

Risk Management knowledge

Experience with GMP / ISO regulations

Education

Degree in Engineering or related technical field

Tools

Lean and Six Sigma Methodologies

Measurement System Analysis

Job description

At Johnson & Johnson we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated and cured, where treatments are smarter and less invasive and solutions are 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 more.

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 : About Orthopaedics

Fueled by innovation at the intersection of biology and technology, we are developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Orthopaedics? Ready to join a team that’s reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports extremities and elective foot and ankle; spine; and robotics and digital surgery.

Your unique talents will help patients on their journey to wellness. Learn more at the role: Process Quality engineer will apply Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle. The incumbent will also use Quality Engineering principles and problem‑solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision. They will apply appropriate risk management to prevent unanticipated failure modes and improve capability of processes. This person will support processes in base business.

As a Process Quality Engineer you will :

• Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
• Support process verification and validation activities.
• Review / analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and other improvement tools and programs.
• Review / analyze whether current product and processes (including actions or decisions conducted) are in compliance with standards such as QSRs, ISO 13485 etc.
• Champion compliance to applicable Global Regulations and standards (e.g., QSRs, ISO EN, and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.
• Partner with R&D and other cross‑functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges.
• Support new product introduction as part of design transfer.
• Conduct investigation, bounding documentation review and approval of non‑conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
• Be accountable and have ownership of Quality metrics, including maintenance and reviewing of leading and lagging indicators of quality.
• Collect data and execute / conduct various analytical / statistical analysis and interpretation as part of process improvements and day‑to‑day support.
• Develop, interpret and implement standard and non‑standard sampling plans.
• Assess effectiveness of measurement tools, destructive tests, non‑destructive tests, measurement system analysis.
• Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls etc. Determine effectiveness of these techniques on previously implemented improvements.
• BE responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.

Qualification / Requirements

• A minimum of a Degree or equivalent, preferably in Engineering and / or related technical field.
• Experience working in both an FDA and European regulatory environment is preferred.
• This position will require relevant experience working in manufacturing / operations.
• Knowledge of product / process Risk Management (FDA and ISO standards) is required.
• Experience with implementing appropriate risk mitigation strategies.
• Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred, including Measurement System Analysis, SPC, DOEs, Reliability etc.

Required Experience and Skills

• Knowledge of statistical software packages is preferred.
• The ability to perform hands‑on troubleshooting and problem solving is preferred. The ability to think on the feet and provide sound judgment is highly desired.
• Understanding of manufacturing equipment and processes is required.
• Understanding of the NPI (New Product Introduction) Process and Process Verification and Validation experience is preferred.
• A thorough understanding of GMP / ISO regulations and validation regulations is preferred.

Heres what you can expect :

• Application review: Well carefully review your CV to see how your skills and experience align with the role.
• Getting to know you: If there's a good match you'll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.
• Staying informed: We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.
• Final steps: For successful candidates you will need to complete country‑specific checks before starting your new role. We will help guide you through these.
• Finally at the end of the process we will invite you to share feedback in a short survey; your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. We're excited to learn more about you and wish you the best of luck in the process!

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months subject to legal requirements, including consultation with works councils and other employee representative bodies as may be required, regulatory approvals and other customary conditions and approvals.

Should you accept this position it is anticipated that following conclusion of the transaction you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies and benefits. Case details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

#LIOnsite

Required Skills : Preferred Skills :

Coaching, Consistency, Controls, Compliance, Critical Thinking, Data Savvy, Engineering, Financial Competence, Good, Automated Manufacturing Practice (GAMP) ISO 9001, Lean, Supply Chain Management, Leverages Information, Process Improvements, Quality Control (QC), Quality Standards, Quality Systems Documentation, Quality Validation, Science, Technology, Engineering and Math (STEM), Application, Technologically Savvy

Required Experience :

Senior IC

Key Skills

Communication, Data Management, Corporate Risk Management, Airport, Financial Planning

Employment Type :

Full-Time

Experience :

years

Vacancy :

1