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Permanent

Senior Quality Engineer

  • Location

    Wiltshire

  • Salary

    Negotiable

  • Sector

    Compliance

  • Job Ref

    88213

  • Contact

    Will Godfrey

  • Published

    15 days ago

Overview

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

Responsibilities:

  • 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.

Experience/Qualifications:

  • 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

  • Trained auditor

You will be rewarded will a fantastic salary and benefits including hybrid working.