Quality Assurance Officer

2 hours ago

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SGS

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Compliance • SaaS • Sustainability

SGS is the world's leading Testing, Inspection, and Certification (TIC) company, providing a comprehensive range of services designed to assure quality and integrity across various sectors. SGS is focused on sustainability, offering climate action services and an all-encompassing ESG portfolio under its IMPACT NOW suite. The company has ambitious targets for growth by 2027, driven by its strategy to address global megatrends. SGS operates globally, providing business assurance, connectivity and products, digital trust, health and nutrition, and solutions for industries and the environment.

10,000+ employees

Founded 1878

📋 Compliance

☁️ SaaS

📋 Description

• 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. • 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.

🎯 Requirements

• Significant work experience in a position with QA responsibility • 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. • Bachelor’s degree (or higher) in Biomedical Sciences or similar field (e.g., pharmacy, bioengineering, nurse, ...) • A nice to have: Detailed understanding of global medical device regulations MDR and IVDR, and medical device directive MDD • A nice to have: Knowledge of accreditation standard ISO 17021-1:2015, ISO 13485, ISO 9001.

🏖️ Benefits

• Flexible schedule and hybrid model • SGS university and Campus for continuous learning options • Multinational environment where you will work with colleagues from multiple continents • Benefits platform