Full-Time Quality Assurance Officer

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 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 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

What is the last date for applying to the job?

Which countries are accepted for this remote job?