We are looking for a Group Quality Process Improvement Engineer to successfully deliver Quality and Operational strategy to deliver corporate goals and objectives. The role will be responsible for the effective implementation of an approved Quality and Operational strategy, and to ensure that it is delivered in accordance with agreed timelines.

Our client is a world leader in wound care and advanced bio-product manufacturing. They work with doctors, researchers, and nurses toward the best outcomes for their patients by developing the highest quality products and capturing clinical data to generate evidence for the use of our products.

This role will report directly to the Head of Quality and be responsible for setting up and delivering a robust process improvement program across all business units in line with the Group’s Quality Management System. The role holder will also be responsible for providing technical support to business units on improving their operational practices and implementing improvements through Lean 6 Sigma techniques.

Main responsibilities:

• Create and implement new quality processes and procedures, as required by business needs
• Ensure the maintenance and improvement of the AMS Label Management system to comply with the requirements of ISO 13485, MDR and MDSAP regulations through the development, implementation, and support of policies and procedures.
• Manage the implementation of new processes, procedures, and tools
• Identify areas where improvements can be made, considering customer requirements and requirements from regulatory bodies
• Plan and execute improvement projects
• Monitor performance, keeping management informed on progress against targets

Qualifications:

• BS or equivalent in a scientific discipline or two years experience in medical device or pharmaceutical industries.
• Must be knowledgeable of the applicable Quality System Regulations and ISO quality requirements.
• Strong interpersonal skills and ability to work effectively with people at all levels of the organization
• Ability to learn quickly and adapt to change
• Knowledge of Software Validation requirements in accordance with GAMP, 21 CFR Part 11 and Eudralex Volume 4 Annex 11
• Familiarity with process improvement methodologies such as Lean, Six Sigma, or Agile
• Ability to work independently and as part of a team within a fast-paced environment.

Benefits:

• A competitive salary that fairly recognises your experience and potential, a bonus scheme and generous benefits package
• Share options in the company so that as the business succeeds, so do you
• 25 days (UK) paid holiday per year. This is in addition to local public holidays.
• Remote and flexible working model
• An open, inclusive, and supportive team where everyone is valued, and all ideas and suggestions are welcomed.