Role Overview I'm currently looking for a QMS Manager to join a leading Medical research company based in Edinburgh. As the QMS Manager you will be responsible for managing the Quality Management System in accordance with ISO 13485:2016. In addition, you will be required to carry out the following:
Key Duties and Responsibilities KEY DUTIES AND RESPONSIBILITIES:
Your duties as the QMS Manager will be varied however the key duties and responsibilities are as follows:
Lead on all quality and regulatory aspects around product development of in vitro diagnostics.
You will help to identify key regulatory and quality inputs early in the product development stages.
Actively contribute to Design History Files and Risk Management documentation.
You will also be responsible for the training of new staff on quality expectations, updating product specifications and documentation for potential certification.
Lead key quality processes, including management review, internal audits & quality agreements.
Role Requirements To be successful in your application to this fantastic opportunity as the QMS Manager we are looking to identify the following on your profile and past history:
Relevant degree in life sciences and preferably a recognised Lead Auditor qualification.
Strong background of working within the IVD industry.
A working knowledge and practical experience with ISO 13485
Key Words: QMS, 13485, Medical Device, Quality Management System, IVD, In Vitro Diagnostics
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.