Quality Assurance Coordinator

Company 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 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
• A Nice To Have: 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 continuous 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.

Seniority level

• Entry level

Employment type

• Full-time

Job function

• Quality Assurance

Industries

• Retail Office Equipment, Consumer Services, and Oil and Gas

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