Senior Process Quality Engineer

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 Med Tech. 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.

Supply Chain Engineering

Quality Engineering

Scientific / Technology

Leeds West Yorkshire United Kingdom

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.

• 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.

• 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…