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Quality System Specialist


Essex - Harlow
£41000 per annum, Excellent Benefits
Permanent
Job Reference
257778/003

Quality System Specialist - Medical Devices

Harlow, Essex

Salary £41,000 pa

Permanent


We are looking to recruit a Quality System Specialist to join the Quality Department within a leading chemical manufacturer that develops chemical technology for the purification of air to preserve life and protect the environment.

The Quality System Specialist alongside the Quality Manager will ensure the company's readiness in compliance with standards and certifications.

Responsibilities & Duties:

  • Support the Quality Manager in the general maintenance of BQMS, regularly update the quality system performance and reporting data
  • Create, review and update relevant SOPs and Work Instructions needed to support/improve BQMS, Including ownership of the document and data control process
  • Administration of change control process
  • Facilitator of Corrective Actions and provide performance report on periodic basis
  • Provide support with CAPA, complaint and product investigation as needed
  • Provide training including generating training materials to attain necessary competence of personnel and/or increase their awareness of BQMS requirements
  • Maintain membership & subscriptions (e.g. BSI)
  • Lead / support regulatory and customer audits ensuring timely closure to open actions
  • Advice / support on regulatory matters as required

It is essential that Candidates have a background working in Quality Assurance within a Medical Device or Pharmaceutical company or similar and have the following experience:

  • Significant experience in a manufacturing environment or equivalent certification
  • Knowledge of international/harmonised standards, such as, ISO 9001 / ISO 13485
  • Knowledge of QA principles and system concept
  • Experience in process control improvement projects

Location: Harlow Essex, on-site car parking

The successful candidate will be working on site, therefore candidates need to be able to travel to the Harlow site on a daily basis.


Please bear in mind that you may not hear from us straight away. Due to the high level of applications we receive every day, we can only respond to applicants whose skills and qualifications are suitable for this position.


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