Our client a leading Medical Device Manufacturer is looking to appoint a Quality Management Systems (QMS) specialist who will be responsible for managing the internal audit program. Supporting the implementation and maintenance of the ISO 13485 certified Quality Management System across the company, including Quality Objectives, NC/CAPA management, and monitoring, measuring and reporting on QMS performance.
RESPONSIBILITIES OF THE ROLE:
• Manage the internal audit program, including scheduling audits and assigning auditors.
• Perform internal audits as assigned
• Provide support during external audits, including collating pre-audit document requests.
• Manage the Quality Objectives procedure.
• Manage the NC/CAPA procedure.
• Provide backup/support for the document control and training activities on MasterControl.
• Provide training to other team members/colleagues as required.
• Any other duties as required.
• Continuous improvement - To initiate, support and lead Continuous Improvement projects as required.
• Health & Safety - All employees are to be aware and understand their health & safety responsibilities as laid out in the company Policy and its associated documentation. All employees have a legal duty to take all care needed for the safety of themselves and others who may be affected by their activities and to co-operate with the employer in complying with statutory requirements
QUALIFICATIONS AND EXPERIENCE:
• Experience of Quality Systems is essential.
• Experience within the Medical Devices industry is highly desirable.
• Excellent working knowledge of Microsoft Office (Word, Excel, OneDrive.)
- Excellent written and oral communication skills in English.