Company Description

SGS – the world’s leading testing, inspection and certification company. 99,600 employees in 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world.

Job Description

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.
• Use of Bizzmine (Quality Management System); user communication and maintenance.

This role will report to the Quality & Regulatory Manager, Business Assurance.

Remote based, open to candidates located across Europe. Candidates 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 updated quality management system documents in Bizzmine.
• Build a good working relationship with the Global Medical Device Certification / Competency /.
• 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

Essential Skills & Knowledge

• 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 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.

Education

Essential

• Bachelor’s degree (or higher) in Biomedical Sciences or similar field (e.g., pharmacy, bioengineering, nursing).

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

• 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 continued learning options.
• Multinational environment where you will work with colleagues from multiple continents.
• Benefits platform.

Why SGS?

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.