Austin Vita is pleased to be offering a great opportunity for a Senior Quality Engineer to join our client, a Global Medical Device business based in Wiltshire. This is a great position for someone with broad scoped quality experience within medical devices and you will be joining a Team of 5 consisting of Quality Manager, QC Team leader, 2 Quality Engineers and a Document Controller
To act as deputy for the site Quality Manager as-and-when required
Supporting customers with their MDR submissions, reviewing, updating and maintaining both Design History Files and legacy Technical Files for compliance
Ensuring Risk Management documentation (including pFMEAs) are up-to-date and in-line with the requirements of the current revision of ISO 14971
Ownership of Quality Agreements, liaising with the Regulatory Department in order to compile and maintain
Reviewing current QMS documentation for accuracy and relevance, updating or obsoleting as required
Providing Quality support for projects (including forced material changes and new product development)
Liaising with the site Quality Manager, Quality Engineers and / or Head of Quality (UK) to assist with product sterilization management
Supporting the site Quality Manager with training, development and mentoring the site Quality Team
Ad-hoc Quality-related tasks, as assigned by the site Quality Manager
Supporting external audits and carrying out internal audits.
Root cause analysis for CAPA's and Non-conformances.
Qualified to degree level or equivalent in a relevant subject
Minimum of 3 years experience in a Quality-focused role, within the healthcare industry
Good working knowledge of Quality and Regulatory requirements for the manufacture and marketing of medical devices, to include experience of working with Design History Files and Technical Files
You will be rewarded will a fantastic salary and benefits including hybrid working.