Join to apply for the Process Quality Engineer role at Johnson & Johnson MedTech.
At Johnson & Johnson, we believe health is everything. Our expertise in Innovative Medicine and MedTech positions us to innovate across the full spectrum of healthcare solutions.
Job Function
Supply Chain Engineering – Quality Engineering (Scientific/Technology).
Locations
Leeds, West Yorkshire, United Kingdom.
About Orthopaedics
We’re developing the next generation of smarter, less invasive, more personalized treatments. Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems.
About The Role
The 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 use quality engineering principles, risk management, and problem‑solving skills to improve products/processes aligned with the overall quality and business vision.
Responsibilities
* 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 comply with standards such as QSRs, ISO 13485, and other applicable regulations.
* Champion compliance with applicable global regulations and standards (e.g., QSRs, ISO, EN, Medical Device Directive) and support during internal and external audits.
* Partner with R&D and cross‑functional partners to ensure proper application of design controls, risk management, and 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. Escalate quality issues as appropriate.
* Own Quality metrics and maintain and review leading and lagging indicators.
* Collect data and perform analytical and statistical analyses 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 and determine effectiveness of these techniques on previously implemented improvements.
* Ensure compliance with company guidelines related to Health, Safety, and Environmental practices.
Qualifications / Requirements
* Minimum of a degree or equivalent, preferably in Engineering or related technical field.
* Experience working in both FDA and European regulatory environments.
* Relevant experience in manufacturing/operations.
* Knowledge of product/process risk management (FDA and ISO standards).
* Experience with implementing appropriate risk mitigation strategies.
* Technical training and experience using statistics, Lean, and Six Sigma methodologies, including measurement system analysis, SPC, DOEs, and reliability.
Required Experience and Skills
* Knowledge of statistical software packages.
* Hands‑on troubleshooting and problem‑solving skills.
* Understanding of manufacturing equipment and processes.
* Understanding of the NPI (New Product Introduction) process and process verification and validation experience.
* Thorough understanding of GMP/ISO regulations and validation regulations.
What You Can Expect
* Application review: We’ll carefully review your CV.
* Short call with recruitment team to discuss fit and answer questions.
* Regular updates on progress.
* Country‑specific checks before start.
* Feedback survey upon completion.
Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone company, DePuy Synthes. The separation is anticipated to be completed within 18 to 24 months, subject to regulatory approvals and other conditions.
Required Skills
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, Quality Services, Quality Standards, Quality Systems Documentation, STEM Application, Supervision, Supply Planning, Technologically Savvy.
Preferred Skills
Customer Centricity, Data Savvy, Document Management, Execution Focus, GAMP, Issue Escalation, Lean Supply Chain Management, Process Control, Process Improvements, Quality Control, Quality Services, Quality Standards, Quality Systems Documentation, STEM Application, Supervision, Supply Planning, Technologically Savvy.
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