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| Job Location | Harlow |
| Education | Not Mentioned |
| Salary | 40,000 - 50,000 per annum, inc benefits |
| Industry | Not Mentioned |
| Functional Area | Not Mentioned |
| Job Type | Permanent , full-time |
Are you looking for a role in Quality Management working to ISO 13485Do you have extensive experience working with and developing QMSWell 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.Role Responsibilities> 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 companies current production and requirements. The current QMS was developed when the company was implemented, and due to its growth, it is now potentially not fit for current and future purpose.As such, they are looking for a Quality Manager with experience in this to come in, 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 potentialbusiness ventures, as well as changes in the global market> Auditing - Supplier and customer - working alongside ISO 13485 within Class 1 Medical DevicesExperience Required> 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 13485In return> 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 businessIf 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