Our client (located in Berkshire, West of London) is considered by many as the market leader when it comes to the manufacturing and sales of diagnostic & medical instruments.
Established for over 100 years and with a recent considerable investment into the business, this is an exciting time to join this growing global brand.
Due to continued growth and new projects, we are looking for a Quality Assurance Officer with a Medical Devices background to join the QA/RA team. Reporting directly to the Head of QA & RA some of your duties will include: -
* Development and Updates on QMS procedures
* Compliance to ISO 13485:2016 and/ or Medical Device Single Audit Programme (MDSAP), FDA and other global requirements
* Participation in the review and approval of processes
* Manage, Maintain and Implement CAPAs (Corrective and Preventative Actions)
* Support the Head of QA & RA with day to day duties as required
It is likely the successful candidate will have the following:
* Minimum 2 years Quality Assurance experience gained within medical devices.
* Strong understanding of ISO 13845
* Previous involvement of set up and/or development of QMS systems
* Working knowledge and practical experience of quality and regulatory guidelines as applied to medical devices.
* Strong communication and relationship building skills
* Be methodical, analytical and highly organised.
How to apply
If the above sounds like your ideal role and you have the skills and attributes as listed above, please forward your CV in a word document format today.
Key words: QA, Quality Assurance, Medical Devices, Med Device, ISO 13845
Product Quality Assurance