Quality Assurance Professional

3 days ago


Oxford, Oxfordshire, United Kingdom Lenntech Search Full time
Job Overview

We are seeking a highly skilled Quality Assurance Professional to join our QA & compliance team. As a key member of the team, you will play a vital role in ensuring our ISO 13485 quality management system is established, implemented, maintained, monitored, and continuously improved.

The ideal candidate will have experience working in a quality assurance role within FDA and EU regulated QMS frameworks for medical device design, development, and manufacture, specifically for ISO 13485.

Main Responsibilities
  • Manage and coordinate document control and training activities via the electronic QMS (eQMS).
  • Contribute to the creation and preparation of documentation; manage the review and approval of documents, including SOPs, WIs, and ensure compliance with Good Documentation Practices, regulatory standards, and company operating requirements.
  • Provide support to users of the eQMS, assisting with initiating change requests and uploading associated documentation.
  • Support the delivery of the Internal Audits, Non-conformance, and CAPA management system in the business.
  • Identify and own opportunities for continuous improvement across the Quality Management System.
  • Perform QMS Gap Analysis to ensure appropriate reviews and approvals have taken place.


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