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Statistical Analysis Process Engineer

Chepstow, Gwent, United Kingdom, £ £ - Annual Annual, Permanent


Statistical Analysis Process Engineer


Salary £DOE

Hatchling Recruitment has an opportunity for an experienced Statistical Analysis Process Engineer to join a rapidly growing business in the Chepstow area.

This is an exciting time to join the business due to further growth plans, which has resulted in the creation of this role.

Duties and Responsibilities to Include

  • Capability analysis and interpretation of supplier data
  • Statistical analysis
  • Ensure the impact of design and process changes are fully assessed using engineering acumen and relevant change control procedures
  • Protocol generation
  • Report writing
  • Identify process problems and non-conformance\'s in manufacturing processes and develop corrective actions
  • Implement GMP (Good Manufacturing Practice)
  • Coordinate the training of manufacturing operators at supplier if required
  • Support internal audits and work under ISO 13485
  • Review procedures for accuracy and make updates using a Document Change Order procedure to reflect process changes, and develop production procedures, standard operating procedures testing and inspection and drawings
  • Drive continuous and process improvements
  • Project management

Skills and Experience Required

  • Degree qualified or equivalent skills from a mechanical, electronic, manufacturing, product engineering-based discipline
  • Highly experienced working within a Quality Management System ISO 13485
  • Understanding of development of manufacturing jigs and fixtures, poke yoke design
  • Excellent process validation and verification expertise including IQ/OQ/PQ DOE and TMQs
  • Understanding of risk analysis documentation, DFMEA & Risk analysis
  • Excellent engineering and root cause analysis problems solving skills
  • An ability to multi-task and work under pressure to meet tight deadlines
  • Experience of working with external tooling companies

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Job Details

Not Specified
Chepstow, Gwent, United Kingdom
£ £ - Annual Annual