We are seeking an experienced Quality Systems professional to join a growing organization. The Quality Systems Specialist will be responsible for maintaining and improving the Quality Management System (QMS) to ensure compliance with applicable and international regulations and standards.
Key Responsibilities:
1. Maintain the Quality Management System (QMS) to ensure that all operations are fully compliant with regulatory requirements.
2. Maintain quality system procedures, work instructions, and records to support business excellence.
3. Ensure timely and accurate document control and change management activities to prevent nonconformity.
4. Track and report metrics and key performance indicators for the Quality Management System to drive continuous improvement.
5. Monitor and trend quality system metrics and prepare reports for management reviews to inform strategic decisions.
6. Support Corrective and Preventive Actions by conducting root cause investigations, effectiveness checks, and documentation to resolve issues efficiently.
7. Assist with risk management processes to mitigate potential risks.
8. Continuously assess the effectiveness of the QMS and ensure processes are improved through collaboration with all departments to achieve organizational goals.
9. Manage the Internal Audit program and support external quality audits to maintain credibility.
10. Document Control - lead for managing SOPs and Document Control to ensure accuracy.
11. Site lead for training compliance to SOPs to ensure employee understanding.
Essential Criteria:
* Flexibility to travel is required to support business activities and collaborate with stakeholders.
* Bachelor's degree in a Science-related discipline to provide a solid foundation for quality expertise.
* Minimum of 3–5 years' professional experience in the Medical Device industry within a Quality Assurance role to demonstrate relevant skills.
* Strong knowledge of current QMS requirements and extensive experience in ISO 13485 to ensure regulatory compliance.
* Proven ability to clearly and concisely communicate with both internal and external stakeholders to build trust and confidence.
* Strong organizational and presentation skills to present complex information effectively.