Questa posizione è in SGS

Il processo di selezione sarà interamente gestito SGS.

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# Company Description We 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. At 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. # Job Description **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. # Qualifications **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** # Additional Information **Why SGS?** * Join a globally recognized and stable company, a leader in the Testing, Inspection, and Certification (TIC) industry. * Enjoy a flexible schedule and work model. * Access SGS University and Campus for continuous learning options. * Thrive in a multinational environment, collaborating with colleagues from multiple continents. * Agevolazioni from our comprehensive benefits platform. **Join Us:** At SGS, we are dedicated to fostering an open, friendly, and supportive culture that thrives on teamwork. We value diversity and provide endless opportunities to learn, grow your expertise, and fulfill your potential. **Please share your CV in English. The role is fully remote. People from other countries can apply as well.**

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[#LI-REMOTE]

📌 Quality Assurance Officer (1 year maternity cover) (Milano)
🏢 Sgs
📍 Milano