Quality Assurance Officer (1 year maternity cover)

SGS

1d•Remote

About The Position

This role is a 1-year maternity cover position for a Quality Assurance Officer. The main purpose of the role is the maintenance of the NB 1639 medical device internal quality management system. The role involves managing daily QA tasks such as updating and maintaining documents under the MDD, MDR, and IVDR schemes, managing the IF database, collaborating on generic scheme documents, and publishing documents on the SGS website. The position also includes maintenance and user communication for Bizzmine (Quality Management System). This role reports to the Quality & Regulatory Manager, Business Assurance, is remote-based, and open to candidates across Europe with a valid work permit.

Requirements

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
Significant work experience in a position with QA responsibility
Bachelor’s degree (or higher) in Biomedical Sciences or similar field (e.g., pharmacy, bioengineering, nurse, or similar)

Nice To Haves

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 working with medical devices
Auditing experience against recognised standards
Medical device training on MDD, MDR, IVDR or ISO 13485
Medical device auditor

Responsibilities

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