QMS Specialist

Lenn Tech Search are working with a fast growing medical device client who have an urgent need for a Quality Systems Specialist to join the QA & compliance team.

You will play a key role in ensuring our ISO 13485 quality management system is established, implemented, maintained, monitored, and continuously improved. This role will have responsibilities including creation and quality review of QMS documentation, ownership of projects driving continuous improvement, management and participation in audits and investigations, monitoring of key QMS performance indicators. You will also develop subject matter expertise in management of the company’s electronic QMS.

• 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 to 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.
• Supporting extension to ISO Scope to include manufacturing of medical devices.
• Supporting notified body and external audits.

• Experience of working in a quality assurance role within FDA and EU regulated QMS frameworks for medical device design, development, and manufacture, specifically for SO 13485.
• 3+ years experience in a similar role.