Job Description

• Reviewing and Maintaining the QMS including all Quality documents and records
• Supporting the audit process
• Monitoring activities relating to non-conformities
• Assisting with regulatory activities and reviewing regulatory documentation
• Monitoring regulatory intelligence

Required Knowledge, Skills, and Abilities

Qualifications

• Demonstrable experience of working with a QMS
• Proven experience of working within a regulated life sciences or healthcare devices industry
• Training/understanding of requirements of ISOs (9001 and/or 13485, 27001)
• Understanding of internal and external auditing processes

Desirable:

• Experience of working under ISO 9001 (and/or ISO 13485, ISO 27001)
• Understanding of quality tools, CAPA, RCA