Senior Quality Engineer

5 days ago

Leeds, United Kingdom HCLTech Full time

Position Overview The Senior Quality Engineer plans, conducts and directs engineering projects or studies including complete projects requiring advanced knowledge of a specialized field. They apply comprehensive and diverse knowledge of engineering principles and practices within broad assignment areas. The Senior Quality Engineer will utilize 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 utilize Quality Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision. He/she will utilize appropriate risk management to prevent unanticipated failure modes and improve the capability of processes. New Product/Process Introduction Partners 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 quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
Conduct benchmarking to develop more effective methods for improving quality
Supports the development of quality engineering and quality compliance with the right skillsets for new product introductions, and product life cycle management.

Compliance/Regulatory
~ Product Quality, Control & Disposition and Performance Standards Analyze/review the effectiveness of preventive and corrective actions. Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality

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 interpretations as part of process improvements and day-to-day support.
Assess the effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis.
Accountability and ownership for sampling plans of all types including the 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 standards for manufacturing data.
Risk Mitigation
Document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond the capability of current controls or whether the 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. Ensures effective quality strategies are created for the validation of test methods, processes and design.


A minimum of a Bachelors Degree, preferably in Engineering or a related technical field. Experience working in both an FDA and European regulatory environment is preferred.
In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
Experience with a proven track record of implementing appropriate risk mitigation.
Technical training and experience using Statistics, Lean and Six Sigma Methodologies are required including Measurement System Analysis, SPC, DOEs, Reliability, etc.
Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making.
Demonstrated project management and project leadership abilities are required.

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