Quality Assurance Officer (1 year maternity cover)
Core
Maintaining the NB 1639 medical device internal quality management system and managing daily QA tasks including document control, complaint management, and regulatory compliance under MDD, MDR, and IVDR schemes.
Role type
Quality Assurance Officer (Medical Devices)
Builds
Quality management system documentation and compliance records for medical device certification
Domain
Medical Devices / Quality Management Systems
Required skills
Quality management systems (QMS), CAPA management, document control, Good Documentation Practices (GDP), MS Office tools, English (fluent)
Preferred skills
Medical device regulations (MDR, IVDR, MDD), ISO 17021-1:2015, ISO 13485, ISO 9001, auditing experience
Technologies
Bizzmine, SGS website
Responsibilities
Manage complaints, compliance queries, and appeals; Perform QA checks on updated QMS documents; Release updated QMS documents in Bizzmine; Maintain knowledge of SGS procedures and external approval criteria; Support development of combined scheme documents.
Seniority
Mid-level, hands-on IC