You will be an integral member of the quality team in achieving objectives and initiatives including driving continuous improvement projects. You will be the Quality subject matter expert (SME) within the organisation supporting manufacturing and systems to ensure compliant and efficient operation.
You will be responsible for however not limited to:
Supporting the Quality & Regulatory Manager in the general maintenance of QMS.
Create, review and update relevant SOPs and Work Instructions needed to support/improve QMS.
Ownership of documents and data control process.
Facilitate Corrective Actions and provide performance report on periodic basis.
Provide support with CAPA, complaint and product investigations.
Generate training materials and provide training to personnel and promote awareness.
Lead/support regulatory and customer audits.
Review CE Mark and FDA Submissions.
Develop and implement validation documents in an ISO controlled environment.The ideal candidate will have a background with a ISO13485, MDD/MDR, IVD, or GMP background within a Quality function supporting manufacturing. Previous working knowledge of CE mark and FDA regulatory submissions is advantageous. You will need to be a collaborator and self-driven professional looking to make a huge impact on an innovative company.
If you are interested in this opportunity, please send your up to date CV to or call Addison on (phone number removed).
STR Limited is acting as an Employment Agency in relation to this vacancy