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Quality Engineer

Job LocationBishopton
EducationNot Mentioned
SalarySalary negotiable
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent,full-timeB

Job Description

As a Quality Lead for site and network complex projects you will be ensuring compliance is considered through all project phases, generate Quality plans, Lead Risk Assessments and Change controls.Client DetailsA global and well established scientific organisation with a focus on making the world healthier, cleaner and safer.Description

  • Lead QA initiatives to maintain and improve site QMS and compliance to ISO 13485, ISO 14971, 21 CFR Part 820 and IVDR.
  • Subject matter expert in technical and facility requirements including standards and specifications for clean rooms, Water Systems.
  • Quality oversight for validation plans and IQ/OQ/PQ reviews.
  • Support Data Integrity programme
  • Support site Quality Management System driving effective Complaint Handling, CAPA system, Change Control, Internal Auditing, Quality Training, and Manufacturing Area Support.
  • Ensure the Quality Management System requirements are established and maintained, and the performance of the QMS is reviewed with Management.
  • Host customer technical visits and customer audits
  • Quality Expert and advisor for supporting functions and support shop floor quality improvement activities
  • Lead and facilitate escalated quality investigations utilising effective problem solving and root cause analysis tools to drive robust CAPA plans
Profile
  • Previous experience within a Quality Engineer role, within a similar industry would be an advantage.
  • Practical application experience in continuous improvement methodologies to improve processes, strengthen quality and drive efficiency. EPM trained and experienced facilitator for PPI activities.
  • Strong analytical ability including the ability to effectively use data in problem solving and to evaluate process changes and impacts.
Job OfferImmediately starts availableSalary from £25k - £36k DOEAnnual bonus, excellent pension contribution, incentives + much more

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