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Date Added: Mon 06/09/2021

Quality Assurance Coordinator

Chesham, UK
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Company: REAL

Job Type: Permanent, FullTime

Salary: £35000 - £45000/annum pension + bonus + benefits

Our client is a fast growing medical device company developing cutting edge products for cancer surgery. Reporting to the Head of Operations, the Quality Coordinator will maintain and improve the company quality management system and work closely with the Regulatory Manager covering and maintaining the RA/QA system.

Responsibilities:

Maintain the company QMS
Key meetings such as the Management Review and Quality Check-in
Internal and supplier audits, participate in external audits
Conduct KPI reporting and ensure all training records are maintained and up-to-date.
Improve awareness, visibility, and communication on quality initiatives to support assigned quality goals and priorities
Managing the CAPA process within the business to ensure that non-conformities are documented, investigated and appropriate action is implemented to prevent recurrence
Liaise with notified body and regulatory authorities as required.
Report KPI on current QA and related activities, the effectiveness of the QMS and identify areas for improvement.
Implement new and revise existing QA procedures.
Provide training sessions in policies, processes and procedure as required.
Perform continuous improvement projects, from concept stages to implementation.
Bring the 'culture of quality' into medical device development.
Supply chain quality management; ensuring that all key suppliers are assessed before commencement of supply and, where necessary, carrying out audits prior to use and on a regular ongoing basis to safeguard the quality of purchased materialsSkills:

Working to quality management systems e.g. ISO 13485 and FDA 21CFR part 820 and part 11.
Knowledge in MDD, IVD and MDR preferred
Medical Device industry experience, preferably in manufacturing and development of electro-mechanical devices with software (although this isn't a deal breaker)
Communication clearly and effectively with third parties, regulatory authorities and management.
Understanding of current EU medical device regulations.
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