Our Client are a leading engineering business based in East Yorkshire. The company currently require a talented Service and Repair Engineer (contract position) to join the business.
Support (and deputise for) the Service & Repair Operations Leader.
Take a leading role in SOP generation and revision to maintain compliance with cGMP's.
Collate and provide interpretation of service and repair data and performance trends for input into NPD Inputs, PMS and Complaints trending.
Monitor, extrapolate and trend Service & Repair data using statistical techniques to recommend root cause analysis, investigations and / or CAPA activities.
Lead the execution of Change Control projects for Service & Repair.
Perform all activities in compliance with relevant GMP and Quality Systems standards and specifically with FDA Quality System Regulation and ISO 13485.
Apply high standards of occupational Health & Safety in the workplace to comply with company policy and procedures.
Oversee the Global Service and Repair department to ensure processes are capable of meeting internal and external regulatory requirements (FDA, BSI, MDSAP).
Provide operational support to the generation and sustainment of Centre Quality Technical Agreements.
Manage the Operational impact on KPI's (Weekly and Monthly).
Support the engineering leadership team and operations leaders and stakeholders in the development of a service and repair supplier portfolio optimised for the needs of the business.
To support Service and Repair cross-functional teams to implement verifiable process improvements based on a clear understanding of cost/benefit analysis.
Exert influence in a matrix organization across multiple Global locations. Be in frequent contact with functional leaders to provide effective communication status of the Service and Repair network, product improvements, process improvements, product launches, potential cost savings, and compliance risks.
Bachelor Degree (or equivalent experience) in one of the following disciplines: Biomedical Engineering, Integrated Logistics Support, Electronics Engineering or Mechanical Engineering.
Must have sustained experience in a medium/high volume regulated industry, preferably with ILS and Project Management experience.
Experience in Reliability Engineering, particularly in reliability tools / techniques.
Appropriate work experience in roles focused on cost saving, efficiency, quality and process improvement, statistical analysis, ideally with Product Lifecycle experience of electro-mechanical equipment.
Previous experience in a Customer facing role would be an advantage.
Work experience in MS Office suite, ideally with high skill in MS Excel and experience using SharePoint.
Project engineering experience in efficiency and process improvement projects utilizing Lean, six-sigma techniques and statistical analysis tools preferably Green Belt trained.
Excellent communication (verbal and written presentation) and interpersonal skills including the ability to work effectively with all levels of internal and external personnel including external regulatory bodies (FDA).
Outstanding analytical, logical and critical thinking skills that encourage innovation and embrace change.
Excellent facilitation and negotiation skills.
Is able to think tactically and obtain information and identify key issues and relationships relevant to a short/medium-range goal or vision.
The ability to work independently and make autonomous problem-solving decisions with minimal guidance and supervision.
Demonstrate continuous improvement in both the application of technical solutions and the development of people, processes and systems.
Competitive contract rates offered.
6 months in duration
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