Description
JOB PURPOSE:The Quality Engineer will devise or adapt new methods or procedures to control or coordinate all aspects of Titanium EBM 3D Printing technology at the Leeds site. They will be an authority in this specific technical field, exercising considerable latitude in determining technical objectives of assignments. They will lead development of new or refined methods to reduce risk, equipment, materials, processes, products and or technical methods while utilizing Quality Engineering tools and practices throughout the product lifecycle. They will utilize Quality Engineering principles and problem solving skills to improve and maintain EBM products/processes that are aligned with the overall Quality and Business vision. They will apply relevant regulations, standards, GxP requirements, and industry best practices to assignments.
SUMMARY OF JOB:
The Quality Process Engineer will be required to:
* Devises or adapts new methods or procedures to control or coordinate all aspects of Additive Manufacturing (Titanium)
* Emerging authority in this specific technical field, exercising considerable latitude in determining technical objectives of assignments.
* Development of new or refined methods to reduce risk, equipment, materials, processes, products and or technical methods
* Utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of Additive Manufacturing (Titanium) products/processes throughout the product lifecycle.
* Utilize Quality Engineering principles and problem solving skills to improve and maintain Additive Manufacturing (Titanium) products/processes that are aligned with the overall Quality and Business vision.
* Utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes.
* Applies relevant regulations, standards, GxP requirements, and industry best practices to assignments.
Major Responsibilities & Duties: Business Improvements
* 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.
Qualifications
* A minimum of a Bachelors Degree, preferably in Engineering or related technical field. Generally requires 5-8 years 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 is 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 providing 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.
* Strong mentoring, coaching and leadership skills are required.
* 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 your Skill set is a match and can facilitate a 12 month contract in Leeds please get in touch.