Job Description

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.

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, ...)

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.

Skills Required