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Quality Investigation Engineer

Edinburgh   •  Negotiable  •  Permanent, Full time

Stop the press!! Calling all Quality professionals who enjoy working across the full product lifecycle - from product concept through to manufacturing support. Within this Quality Investigation Engineer role you will have the opportunity to work with the quality systems, continuous improvement, verification/validation activities etc.

Role Responsibilities:

  • Monitor and report on all activities, processes, and procedures of the quality management system.
  • Assist in the logging, investigation, analysis and documentation of complaints, non-conforming product and CAPA.
  • Support Supplier approvals and re-assessments in accordance with planned requirements.
  • Create, maintain and evaluate product/process trends, design and participating in process and product changes to improve product quality.
  • Contribute to the development of company policies, processes, and procedures.
  • Inspection and release of materials, processes, and products (on-site or remote), ensuring compliance with stated requirements.
  • Assist in risk assessment activities for relevant processes/products (i.e. dFMEA, pFMEA) ensuring compliance with ISO14971.
  • Assist in the validation planning and preparation of processes/products which require validation.
  • Support document control activities.
  • Support QMS training activities.

Experience Required:

  • Strong written and verbal communication skills.
  • Strong root cause/corrective action skills.
  • Strong analytical, problem solving skills.
  • Experience of working to quality & regulatory standards including ISO13485.
  • Comfortable with dealing with contractors, clients & the regulatory authorities.
  • Familiarity with ERP, electronic document control systems, CAPA and training software packages.
  • Ability to develop good working relationships with colleagues at all levels of the organisation and perform both independently and as part of a team.

This role will require infrequent travel to local CEM partner so a driving license is required.

If this role is of interest please apply or contact Will Hay via email at Will.Hay@cpl.com

  • Agency: Cpl Life Sciences
  • Reference: JO-2303-511506
  • Posted: 1st March 2023
  • Expires: 29th March 2023

Cpl Life Sciences

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