Job Description
JOB TITLE: Senior Quality Engineer – New Product Introduction
Location: Leeds, UK
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. They may coordinate and direct the activities of technical support staff and are responsible for the technical development of assigned staff.
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. This person will support processes in the base business.
Major Responsibilities & Duties:
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.
* Supports new product introduction as part of design transfer.
* Support the complete process verification activities and should have a completed 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.
Qualifications
* A minimum of a Bachelors 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.