Senior Quality Engineer

Salary: £57,600 – £67,200 per year

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.

Austin Fraser is acting as an Employment Agency in relation to this vacancy.

Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.

Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.