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Senior Quality Engineer

2 months ago

Leeds, Leeds, United Kingdom HCLTech Full time
{"Job Title": "Senior Quality Engineer", "Job Summary": "We are seeking a highly skilled Senior Quality Engineer to join our team at HCLTech. As a key member of our quality team, you will be responsible for planning, conducting, and directing engineering projects or studies, including complete projects requiring advanced knowledge of a specialized field. You will apply comprehensive and diverse knowledge of engineering principles and practices within broad assignment areas, coordinate and direct the activities of technical support staff, and be responsible for the technical development of assigned staff.

Key Responsibilities:

* 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.
* Support the complete process verification activities and have a thorough understanding of Validation documents.
* Support on the Equipment IQ, OQ & PQ.
* Support the new test method development and validation.

Business Improvements:

* Support quality improvement initiatives such as process and product characterizations that lead to continuous/cost improvements.
* 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 and quality compliance with the right skillsets for new product introductions, and product life cycle management.

Compliance/Regulatory:

* Analyze whether current products and processes (including actions or decisions conducted) comply with standards such as the QSRs, ISO 13485, etc.
* Product Quality, Control & Disposition and Performance Standards: Analyze/review the 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:

* 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.
* Develop, interpret, and implement standard and non-standard sampling plans.
* 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.
* Assess and interpret common versus special cause variation in manufacturing processing and determine the adequacy of current process limits.

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. Determine the effectiveness of these techniques on previously implemented improvements.

Strategic:

* Ensures effective quality strategies are created for the validation of test methods, processes, and design.

Qualifications:

* A minimum of a Bachelor's Degree, preferably in Engineering or a related technical field. Generally requires 4-6 years of related experience.
* Experience working in both an FDA and European regulatory environment is preferred.
* This position will require relevant experience working in manufacturing/operations.
* 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.
* The ability to perform 'hands-on' troubleshooting and problem-solving is required. The ability to think on the feet and provide sound judgment is highly desired.
* Good technical understanding of manufacturing equipment and processes is required.
* Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.
* A thorough understanding of GMP/ISO regulations and validation regulations is preferred.
* Advanced knowledge and proven leadership in the areas listed in the Duties and Responsibilities associated with the position.
* Demonstrated project management and project leadership abilities are required.

If you are a motivated and experienced Senior Quality Engineer looking for a new challenge, please submit your application.

We are an equal opportunities employer and welcome applications from all qualified candidates.

Note: The above job description is a general outline of the key responsibilities and qualifications for the position. The actual responsibilities and qualifications may vary based on the specific requirements of the role and the company.

HCLTech is an equal opportunities employer and welcomes applications from all qualified candidates.

Please note that the job description is subject to change based on the company's needs and requirements.

We are committed to providing a diverse and inclusive work environment and welcome applications from all qualified candidates.

Thank you for your interest in HCLTech.

Best regards,

[Your Name]"}