Quality Assurance Officer (1 year maternity cover)

Main Purpose of Role: • Maintenance of the NB 1639 medical device internal quality management system. • Managing of daily QA tasks: - Updating and maintenance of documents under the MDD, MDR and IVDR scheme, - Management the IF database, - Collaboration on generic scheme documents, - Publishing of documents on the SGS website, - Bizzmine (Quality Management System); user communication and maintenance. This role will report to the Quality & Regulatory Manager, Business Assurance. It is remote based, and we are open to candidates located everywhere across Europe. But they must hold a valid work permit for their country of residency. Key Accountabilities: • Management of complaints, compliance queries and appeals, • Management of continual improvement, • Management of document control and records, • Perform quality assurance check on updated quality management system documents, • Release of updated quality management system documents in Bizzmine, • Build a good working relationship with the Global Medical Device Certification / Competency / Technical and Clinical Manager(s), and other Global Medical Device Team members, • Undertake personal professional development and ensure appropriate training records are updated, • Provide technical support to all parts of the business, • Maintain a full knowledge and understanding of SGS procedures, regulations, guidance documents (e.g., MDCG) and external approval criteria, • Support the development and maintenance of combined scheme documents. Skills & Knowledge Essential: • Good working knowledge of quality management systems including CAPA management, document control and good documentation practices (GDP), • Detail oriented, • Strong organisational skills, • Ability to organise own workload considering priorities set by the global medical device quality manager, • Ability to adapt quickly and demonstrate flexibility, • Ability to work in a team, • Ability to write clear procedures, • Good working knowledge of the main MS office tools (Word, Excel, Outlook), • Fluent written and spoken English. A nice to have: • Detailed understanding of global medical device regulations MDR and IVDR, and medical device directive MDD, • Knowledge of accreditation standard ISO 17021-1:2015, ISO 13485, ISO 9001. Experience Essential: • Significant work experience in a position with QA responsibility. A nice to have: • Experience working with medical devices, • Auditing experience against recognised standards. Qualifications Essential: • Bachelor’s degree (or higher) in Biomedical Sciences or similar field (e.g., pharmacy, bioengineering, nurse, or similar) A nice to have: • Medical device training on MDD, MDR, IVDR or ISO 13485 • Medical device auditor Performance Indicators: • Turnaround time for compliance issues/complaints/ appeals, • Efficient running of QMS and release of quality management documents. Please send your CV in English