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
* 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
* Knowledge of accreditation standard ISO 17021-1:2015, ISO 13485, ISO 9001
Experience
* Significant work experience in a position with QA responsibility
* A nice to have: Experience working with medical devices
* Auditing experience against recognised standards
Qualifications
* 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
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.
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