You would be working as direct support to the Quality Manager of a Biomaterials company to ensure compliance with ISO13485:2016.
As the company is expanding, the Quality Management department is gaining more and more responsibilities and the demand for quality assurance personnel is increasing.
- Assist the Quality Manager with the maintenance of the ISO 13485 Quality Management System (QMS).
- Create, revise and control documents including standard operating procedures, supplier approvals, forms, and templates. This will involve close collaboration with people in manufacturing, R&D, and logistics.
- Initiate, follow up and close deviations, change control and CAPA (corrective action preventative action).
- Keep accurate records and filing of documents.
- Review manufacturing batch documents, coordinating with the Quality Manager for batch release of medical device components.
- Keep the internal training database up to date with all relevant documents and coordinate quality training activities.
- Work with the production team to provide operational QA oversight of manufacture in ISO Class 7 Cleanrooms.
- Promote continuous improvement within the organisation.
- Perform such other tasks that may be required from time to time.
The ideal candidate will have experience working in a quality-controlled environment within industries such as biomaterials, medical devices, pharmaceuticals or biotechnology. You will be enthusiastic, eager, resilient and self-motivated. You will be able to organise your own work load and be able to carry out all quality management duties in the case of their absence. Excellent written and verbal communication skills and competency with MS Office software and project management software are key.
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