Are you looking for a role in Quality Management working to ISO 13485?
Do you have extensive experience working with and developing QMS?
Well REED Engineering are excited to be working with a long standing client who are leaders in the supply and distribution of Class 1 medical devices to industry.
They are currently looking for an experienced Quality and Regulatory Affairs Manager to join their team working out of their Harlow office.
> Assessing previous and current processes to identify opportunity for improvement, discussing with the teams from production to supply chain
> Managing supplier and customer complaints, running monthly reviews on previous and current complaints
> Developing and managing a new QMS to fall in line with their current production and working methods. The company has expanded over recent years, and their QMS needs updating to remain in-line with the increasing demands of regulatory standards and an expanding customer portfolio. They are looking for a Quality Manager with experience in this field to assess the current system, and identify how to further develop the companies procedures
> Discussing and negotiating Regulatory Affairs with suppliers and international bodies, to further understand and display the requirements and responsibilities of the business both for existing suppliers and countries of trade, and for upcoming and potential business ventures, as well as changes in the global market
> Auditing - Supplier and customer - working alongside ISO 13485 within Class 1 Medical Devices
> This role will require previous experience working within QMS, and the ability to understand the needs of a business and developing a new QMS to fit business needs
> Understanding and experience with Regulatory Affairs
> Previous experience working with the medical device industry - working to ISO 13485
> Previous experience with both internal and supplier audits - Ideally being a lead auditor with ISO 13485
> You will receive a competitive salary
> Training opportunities to further you knowledge within this role
> A clean, welcoming and comfortable environment, working within a family run business
If you have the necessary experience with QMS, Regulatory affairs and ISO13485, and would like to be considered for the role, please send a copy of your CV through to