Overview
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.
Main Purpose of Role
* Maintenance of the NB 1639 medical device internal quality management system.
* Managing daily QA tasks:
* Updating and maintenance of documents under the MDD, MDR and IVDR scheme,
* Management of 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, and auditing experience against recognised standards.
* Essential: Bachelor’s degree (or higher) in Biomedical Sciences or similar field (e.g., pharmacy, bioengineering, nurse, ...)
* 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?
* 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 continuos learning options.
* Multinational environment where you will work with colleagues from multiple continents.
* Benefits platform.
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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