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 :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, ...)
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.