Quality Assurance Coordinator

**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.**

**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.