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 daily QA tasks.
* Updating and maintaining documents under the MDD, MDR and IVDR scheme.
* Managing the IF database.
* Collaboration on generic scheme documents.
* Publishing documents on the SGS website.
* Using Bizzmine (Quality Management System); user communication and maintenance.
This role will report to the Quality & Regulatory Manager, Business Assurance.
Location: Remote. Candidates located anywhere across Europe are welcome, provided they 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 checks 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 Managers 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.
Nice to Have
* Detailed understanding of global medical device regulations MDR and IVDR, and medical device directive MDD.
* Knowledge of accreditation standards ISO 17021-1:2015, ISO 13485, ISO 9001.
Experience
Essential
* Significant work experience in a position with QA responsibility.
* Bachelor’s degree (or higher) in Biomedical Sciences or similar field (e.g., pharmacy, bioengineering, nursing, ...).
Nice to Have
* Experience working with medical devices.
* Auditing experience against recognised standards.
* 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.
Additional Information
* Global and very stable company, world leader in the TIC (Testing, Inspection and Certification) industry.
* 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.
Please send your CV in English.
Join Us: At SGS we believe in innovation, collaboration, and continuous improvement. We offer a supportive and inclusive work environment that encourages professional growth and personal development.
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