Validation Engineer

Location: Leeds, West Yorkshire
Salary: £35,000 pa
Reference: LG / BBBH15102
Type: Permanent
Sector: Other Business Support, Professional & Technical Support
Deadline: 22/11/2021

The company

Brewster Partners are recruiting for an established and market leading manufacturing business based in Leeds. As the Validation Engineer you will report directly into the Operations Manager, the successful candidate will be responsible for managing and leading all quality activities within the site in addition to driving quality improvements across the organisation.

Must have excellent knowledge and ability to validate medical machinery.

The job

  • Degree qualification in Bio-medical Engineering, Science, Mechanical Engineering or Manufacturing
  • Design or plan validation protocols and other documentation for equipment, processes or products meeting internal and external safety and quality requirements.
  • Conduct validation or qualification tests for new or existing processes, equipment or products in accordance with internal protocols, procedures or external standards.
  • Lead and provide an analysis of data by using software such as Minitab or similar on the results of test data to show the necessary quality performance stability requirements have been met.
  • Managing the sites Validation Master Plan and Calibration Master Plan.
  • Perform product testing in the laboratory which includes determining appropriate test methods, housekeeping, maintenance of test equipment and well as testing and monitoring protocols and recordkeeping as required.
  • Review and revise specifications for products and processes, including creating drawings in Easy Cad software.
  • Supporting the Quality Manager with ensuring that the quality management system as defined in ISO 13485 is implemented and maintained.
  • Write or review Standard Operating Procedures or Work Instructions and other quality documentation as necessary.
  • Maintain a technical skills profile to meet the needs of the business.
  • Provide a lead in problem solving, supplying targets for yield improvements, conducting failure and root cause analysis including risk assessments and FMEA activities.
  • Support the management, investigation and analysis of Supplier and Customer quality complaints
  • Implement improvements to production processes that lead to overall increases in product quality.
  • Other duties as necessary to support the operations of the Quality and Regulatory Affairs Department.

The person

  • Thorough knowledge of validation processes for machinery and products as per ISO 13485 and other ISO or international standards
  • 2+ years in Quality department role
  • ISO 13485 implementation experience
  • Quality control/assurance background
  • Manufacturing industry experience
  • Technically astute, interpreting technical drawings
  • Degree qualification in Bio-medical Engineering, Science, Mechanical Engineering or Manufacturing

The benefits

£35,000 pa


Lee Gibbons
Associate Key Account Director
Brewster Partners Recruitment Group


To apply for this job, please send your CV to the email above or to quoting "Vacancy: Validation Engineer, Reference: LG / BBBH15102". Thank you for your interest.