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.