Job Summary

My client is a high tech IVD business that pride themselves on being on the cutting edge of science in this field, they are now looking for a Senior Quality Coordinator to join their growing team.

Job Overview

•To oversee the Quality Management System aligning with the SVP for operations and development.
•To co-ordinate and schedule Quality Team regular assignments such as CAPAs and internal audits effectively escalating to management where required.
•Take a lead role in the administration and execution of Quality System.
•Support project teams in QMS activities as required.
•Take a lead role in reviewing and identifying improvements to QMS procedures.
•Take a lead role in third party audits (e.g. customer Notified Body or Competent Authorities) in cooperation with the headquarter where required.
•Align changes in regulatory standards with RA Officer to ensure that is proactively identifying and implementing changes to the QMS ensuring the organization is recognized as a knowledgeable and quality, regulatory partner
•Work closely with the QA Coordinator to ensure required updates to the QMS system are made.
•Work closely with the QA Coordinator to ensure alignment with head office on quality and regulatory requirements.
•Keep up to date through working knowledge of regulatory industry practices and standards, FDA and CE/IVD best practices and apply to projects.
•Take part in compliance/regulatory conversations with customers.
•Actively contribute to team meetings and regularly share and encourage the use of best practices within the industry with the software development teams.
•Perform related duties as assigned

Skills Required

•Degree educated or relevant and substantial experience
•Self-motivated and disciplined
•Strong drive and determination
•Very strong quality focus
•Experience working with in Quality in a software environment would be preferable.

Posted 4 days ago

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