QA Staff Engineer, DePuy Synthes
Beeston, Leeds, United Kingdom
DePuy Synthes, a member of Johnson & Johnson's Family of Companies, is investing in early stage research and insights to build our long-term pipeline and enable us to implement innovative disease and care pathways on behalf of customers and the patients we all serve. As this investment includes attracting top talent, DePuy Synthes Quality department is recruiting for a Staff QA Engineer
What you're great at
You have a strong technical background with an ability to plan, direct, and conduct projects of major scope and significance to the Company with technical responsibility for, organizing, executing and coordinating assignments. You will have a passion to develop and mentor more junior staff.
You will be a good communicator who is able to make data based decisions and be able to simplify complex issues to various audiences across multiple functions. You will use Quality Engineering principles and problem-solving skills to improve and maintain develop products/processes that are aligned with the overall Quality and Business vision.
Ensuring effective risk management to prevent unanticipated failure modes and improve capability of processes.
Responsibilities will include:
You will support processes in Base Business and supervise, lead and mentor other engineers and technicians across multiple sites and/or various geographic regions.
• Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
• Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
• Conduct benchmarking to develop more effective methods for improving quality
• Supports the development of quality engineering, quality compliance, quality leadership talents with the right skill sets for new product introductions, and product life cycle management.
• Review/analyze whether current product and processes (including actions or decisions conducted) comply to standards such as the QSRs, ISO 13485, etc.
• Champions 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.
• Conduct periodic line audits to assess for production controls such as lot segregation. Review results of area audits to ensure that corrective and preventive actions are adequate.
Product Quality, Control & Disposition and Performance Standards
• Lead and maintain Material Review Board.
• Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
• Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.
• Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.
• Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality
Production/Process Controls including Control Plans
• Partners with J&J Global Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management; and the investigation/correction of process failures when needed.
• Develop measurement systems/capabilities, destructive tests, non-destructive tests for manufacturing processes
• Develop control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.
• Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
• 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.
• Accountability and ownership for sampling plans of all types including acceptability of risk given the product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. including assessing, applying and interpreting acceptance sampling standard for manufacturing data.
• Assess and interpret common versus special cause variation in manufacturing processing and determine adequacy of current process limits.
• Document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs
• 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
• Conduct strategic planning with site leaders and Product Engineering Team. Partnership with other functions to establish business priorities and resource allocation
• Ensures effective quality strategies are created for the validation of test methods, process and design.