Our client, a Medical Device manufacturer, is seeking a talented Quality Specialist to join their team. As a Quality Specialist, you will play a crucial role in maintaining and improving their Quality Management System (QMS), ensuring compliance with regulatory standards and driving continuous improvement.

Responsibilities:

Maintain and update our client's QMS, aligning it with the 13485 certification standard requirements.
Lead both external and internal audits, ensuring regulatory compliance at all times.
Oversee the CAPA (Corrective and Preventive Action) management system, monitoring and tracking progress.
Collaborate with the Production team to develop and implement robust manufacturing processes that meet customer expectations.
Work closely with various stakeholders, including design teams, suppliers, manufacturing teams, and customers, to drive continuous improvement and compliance.
Prepare and deliver internal training sessions on ISO13485 and ISO14001.
Qualifications:

Minimum of 2 years' practical experience in Quality Management systems, ideally with ISO13485 knowledge.
Positive and proactive attitude, with a can-do mindset and focus on continuous improvement