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Validation Engineer

PE Global
Job LocationLeamington Spa
EducationNot Mentioned
SalarySalary negotiable
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypeContract, full-time

Job Description

Responsible for maintaining the quality management system procedures for the Leamington Spa facility. Administer Leamington Spa quality management system and corrective and preventive action system.Responsibilities:

  • Quality Engineer that has an understanding of mechanical engineering ideally
  • Must be good at investigating issues and getting on the manufacturing floor with a good understanding of processes
  • Very hands on role.
  • Administer quality management system for the Leamington Spa facility, standard operating procedures and work instructions; adhering to document control and quality management procedures (15%)
  • Provide Quality Engineering support for production projects, leading validation activity & change management. (30%)
  • Create and maintain metrology programs for a range of precision metrology equipment Surface Finish Analyzer, Air Gages and inspection techniques such as, Roundness Testing, and coordinate measuring machines (CMM’s) (10%)
  • Provide Quality System training to all Leamington Spa site employees, And ongoing in QMS releases and updates (10%)
  • Assist in the management of the CAPA system, Lead the investigation of non conformances, and lead the CAPA plan for timely closure (10%)
  • Lead the development and evaluation of Statistical Process control within the manufacturing facility (10%)
  • Performs and documents First Article Inspections Requirements (FAIR) on new products or after changes to a process (5%)
  • Perform internal and external audits (5%)
  • Preparation of Quality performance reports (5%)
    • Education: Bachelor’s degree in Engineering, Science or related discipline, Ideally Engineering over Science.Licenses/ Certifications:Ideally ISO13485 lead auditor - not essential, knowledge of IS9001 also considered.Experience:
  • Minimum 4 years experience working in Metrology/Validation role ideally in the Medical Device industry.
  • Experience from Automotive industry considered.
  • Excellent knowledge of statistical techniques, use of precision metrology equipment, CMM programing, Gauge R & R
  • Proven knowledge of equipment validation and software validation in the Medical/Pharmaceutical industry.
    • Competences:
  • Communication, assimilation of data, working relationships across divisions.
    • Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert.

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