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Project QA Consultant

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    Other Locations

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    Alex Podolski

  • Published

    16 days ago


Austin Vita are currently partnered with a Medical Device company, who are looking for additional help in their QA and RA departments to help with a new complaints and PMS process, due to a few internal procedural changes. This is a half remote, half on site (in the Reading area) role for a 6-9 month project. Further details are below on the project:

PMS processes include complaint handling, Corrections & Removals and Managing PMS.

The role:

  • implementation of PMS procedures, work instructions, templates, forms, and so on in line with the company's process

  • work across QA, RA, Clinical, Risk, R&D to understand the company-wide impact of this project

  • prepare and complete QMS transition planning, and impact assessments (for complains, CAPA and PMS)

Essential experience:

  • demonstrable knowledge in Medical Devices

  • excellent knowledge of Med Device requirements, regulations and other standards (including 13485, but also 14971, MDR, FDA, and any equivalent)

  • ability to work to meet QMS requirements (and experience doing so)

  • working knowledge of PMS and the relevent requirements / procedural writing

If the above sounds of interest, please do not hesitate to apply, and I will get in touch shortly after.

Austin Fraser is acting as an Employment Business 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.