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Senior Product Quality Engineer

2 months ago

Leeds, Leeds, United Kingdom ALOIS Solutions Full time
Job Description

Job Title: Senior Product Quality Engineer

Job Summary:

We are seeking a highly skilled Senior Product Quality Engineer to join our team at ALOIS Solutions. The successful candidate 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.
  • Coordinate and direct the activities of technical support staff and be responsible for the technical development of assigned staff.
  • Utilize Quality Engineering tools and practices for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.
  • Apply Quality Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision.
  • Utilize appropriate risk management to prevent unanticipated failure modes and improve the capability of processes.
  • 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.

Requirements:

  • 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.