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Quality Assurance Specialist

Oxford, UK

The Role

The Quality Assurance Specialist supports the maintenance of Integrated Quality Management System, ensuring that Perspectum’s products and services are fit for purpose, consistent and meet both external and internal requirements. They are pivotal in supporting the activities required to meet various quality standards.

Responsibilities

  • Preparing and implementing quality assurance policies and procedures.
  • Performing quality audits, documenting quality assurance activities and creating audit reports identifying and resolving quality issues
  • Creating training materials and supporting the various department in the creation of work instructions
  • Addressing and discussing issues and proposed solutions with superiors
  • Ensuring that standards and regulation are observed
  • Individuate area of improvements and making recommendations for improvement
  • Analyzing quality records and reports to form recommendations for improvements
  • Being responsible for nonconformity and CAPA maintenance
  • Identify and present Continuous Improvement projects as a result of Non-conformities and CAPA root cause investigations.
  • Interface with clients and other relevant stakeholders as necessary

Essential Requirements

  • Educated to A-Level or higher
  • Internal Auditor for ISO 13485 or Internal Auditor for ISO 9001 (or relevant demonstrated experience in auditing) 
  • Experience within the Medical Devices or pharmaceutical sector
  • Experience in maintaining and developing a QMS with specific knowledge of ISO 13485.
  • Experience in CAPA Management
  • A pragmatic and self-starter mindset
  • An ability to leverage influence with key stakeholders and drive change to ensure best practice and to drive the continuous improvement
  • Excellent written and spoken communication skills
  • Excellent attention to detail
  • Ability to work independently and as part of a team
  • Excellent analytical and problem-solving skills
  • Effective time management - working to deadlines
  • Experience working with Quality Management Systems and Processes
  • Experience with continuous improvement techniques

Desired Requirements

  • Working to ensure GCP compliance
  • Knowledge of Information Security standards such as ISO 27001
  • Knowledge of ISO 14971
  • Knowledge of MDR

Interested in this position?

We are always looking for brilliant people to join us here at Perspectum Diagnostics.

Use the form below to send us your application.