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Quality Manager

Empty Box Recruitment Ltd
Job LocationHapton, Burnley
EducationNot Mentioned
Salary45,000 - 50,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

Our client operates in the Medical Devices sector of business and the successful candidate will need to work within this regulatory framework in the technical department and be responsible for the Quality Management System (QMS) and for ensuring that theQMS meets ISO 13485, MDSAP (Medical Device Single Audit Programme) and other international standards and regulations required by the business.Main responsibilities include:

  • Responsible for the management and implementation of the QMS and its sub-systems and processes and ensuring it meets business and regulatory needs.
  • Responsible for leading and managing members of the Quality team, their output and ensuring their continued development.
  • Ensure the correct resources are in place to support implementation and maintenance of the QMS for current business needs and the future.
  • Ensure effective and compliant release of product from process to process and to the Customer including providing sterility assurance where applicable.
  • Ensure that audit capability is developed and maintained as required by business needs.
  • Deliver training in QMS topics to all levels of the business and support all staff inductions with a QMS introduction session as appropriate to their role.
  • Champion Quality and a Quality culture within the business and provide proactive input to all departments on Quality related issues.
  • Escalate issues appropriately and in a timely manner.
  • Be the key management contact for QMS and quality performance of the business for customers and suppliers.
  • Support or work closely with other managers to conduct investigation and disciplinary/capability processes, recruitment, project delivery and staff training & development.
  • Work on and/or recommend special projects to help achieve business strategies or deliver a Quality project or initiative.
  • For all tasks, make suggestions for continuous improvement of processes and implement where applicable / requested to do so.
The ideal candidate will have the following:
  • Bachelor level degree or equivalent in a relevant Quality Management, Engineering or Science discipline.
  • Minimum of 5 years experience within a manufacturing based medical devices business regulated to ISO 13485 in a quality role with demonstrable understanding of ISO 13485 and its practical application to a medical devices business.
  • A minimum of 2 years experience in a supervisory or managerial position with demonstrable successes in leading and inspiring teams.
  • Demonstrable experience in quality engineering field / topics such as process control, error proofing, failure investigation and root cause analysis, CAPA, data collection and analysis, batch records, in-process testing/checks, CTQs, defect classifications,visual standards, GRR and the application of statistics.

Keyskills :
CAPAData CollectionProcess Control

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