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Senior Quality Assurance Manager
2 months ago
At HCLTech, we are seeking a highly skilled Senior Supplier Quality Engineer to join our team. This role will be responsible for planning, conducting, and directing engineering projects or studies, including complete projects requiring advanced knowledge of a specialized field.
Key Responsibilities:- Apply comprehensive and diverse knowledge of engineering principles and practices within broad assignment areas.
- Utilize Quality Engineering tools and practices for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.
- 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 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.
- Support the development of quality engineering and quality compliance with the right skillsets for new product introductions and product life cycle management.
- 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.
- 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.
- A minimum of a Bachelor's 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.
