pWe are SGS – the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world. /ppAt SGS, we have an open corporate and international culture.

We offer
a dynamic work environment in a leading global company. Our high professional standards and our sustainability approach guarantee you a future-oriented work environment. We invest in our employees for the long term and are committed to supporting your development within the company. Our business principles include: Integrity, Health, Safety Environment, Quality Professionalism, Respect, Sustainability, and Leadership. /ph3Main Purpose of Role /h3ulliMaintenance of the NB 1639 medical device internal quality management system. /liliManaging 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. /liliThis role will report to the Quality Regulatory Manager, Business Assurance. /liliIt 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. /li /ulh3Key Accountabilities /h3ulliManagement of complaints, compliance queries and appeals. /liliManagement of continual improvement. /liliManagement of document control and records. /liliPerform quality assurance check on updated quality management system documents. /liliRelease of updated quality management system documents in Bizzmine. /liliBuild a good working relationship with the Global Medical Device Certification / Competency / Technical and Clinical Manager(s),



and other Global Medical Device Team members. /liliUndertake personal professional development and ensure appropriate training records are updated. /liliProvide technical support to all parts of the business. /liliMaintain a full knowledge and understanding of SGS procedures, regulations, guidance documents (e.g., MDCG) and external approval criteria. /liliSupport the development and maintenance of combined scheme documents. /li /ulh3Skills Knowledge /h3h3Essential /h3ulliGood working knowledge of quality management systems including CAPA management, document control and good documentation practices (GDP), /liliDetail oriented, /liliStrong organisational skills, /liliAbility to organise own workload considering priorities set by the global medical device quality manager, /liliAbility to adapt quickly and demonstrate flexibility, /liliAbility to work in a team, /liliAbility to write clear procedures, /liliGood working knowledge of the main MS office tools (Word, Excel, Outlook), /liliFluent written and spoken English. /li /ulh3A nice to have /h3ulliDetailed understanding of global medical device regulations MDR and IVDR, and medical device directive MDD, /liliKnowledge of accreditation standard ISO 17021-1:2015, ISO 13485, ISO 9001. /li /ulh3Experience /h3h3Essential /h3ulliSignificant work experience in a position with QA responsibility. /li /ulh3A nice to have /h3ulliExperience working with medical devices, /liliAuditing experience against recognised standards. /li /ulh3Qualifications /h3h3Essential /h3ulliBachelor’s degree (or higher) in Biomedical Sciences or similar field (e.g., pharmacy, bioengineering, nurse, or similar) /li /ulh3A nice to have /h3ulliMedical device training on MDD, MDR, IVDR or ISO 13485 /liliMedical device auditor /li /ulh3Performance Indicators /h3ulliTurnaround time for compliance issues/complaints/ appeals, /liliEfficient running of QMS and release of quality management documents. /li /ul #J-18808-Ljbffr

📌 Quality Assurance Officer (Lombardia)
🏢 SGS Italia
📍 Lombardia