Quality Assurance Officer

Quality Assurance Officer (1 year maternity cover)

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• Full-time

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:

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• Maintenance of the NB 1639 medical device internal quality management system.
  

Managing of daily QA tasks:

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• 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:

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• 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.
  

Skills & Knowledge

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• 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:

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• 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

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• Significant work experience in a position with QA responsibility.
  

A nice to have:

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• Experience working with medical devices,
  
• Auditing experience against recognised standards.
  

Qualifications

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

A nice to have:

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• Medical device training on MDD, MDR, IVDR or ISO 13485
  

Performance Indicators:

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• Turnaround time for compliance issues/complaints/ appeals,
  
• Efficient running of QMS and release of quality management documents.
  

Why SGS?

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• Join a globally recognized and stable company, a leader in the Testing, Inspection, and Certification (TIC) industry.
  
• Enjoy a flexible schedule andwork model.
  
• Access SGS University and Campus for continuous learning options.