|Job Ref:||204728950||Employer:||cv-library.co.uk||Industry:||Civil and Structural||Job Type:||Permanent||Country:||United Kingdom||City:||Manchester||Address:||Post Code:||M13||Salary:||£25000 - £35000/annum To £35k plus benefits||Post Date:||05/10/2016 02:45|
Quality Engineer / Manager (Medical, QMS, Sub-contract) |
To £35k plus benefits
Our client is a successful and growing medical devices start-up company developing a revolutionary diagnosis of various cancers and pre-cancerous conditions. Their unique product is a new generation of diagnostic devices that remove subjectivity, increase accuracy and deliver results in real-time, allowing for the improvement and extension of clinical screening programmes, globally.
Due to continued growth they now have a requirement for a dynamic self-starting Quality Engineer seeking early responsibility and progression to Quality Manager, who will ensure that the company designs, develops, manufactures and sells medical devices in accordance with the relevant international and national regulations and standards.
Qualifications and experience
• Degree in a scientific/technical discipline with competency in biomedical sciences, engineering and electronic/electrical products.
• Working with a QMS in a manufacturing environment; preferably ISO 13485 compliant medical devices.
• Experience of working in compliance with FDA regulations would be advantageous.
• Project management experience would be advantageous
• Administer the company QMS and ensure that it remains compliant with all relevant standards and regulations as these change.
• To maintain the registrations, certifications and accreditations required for activities worldwide and obtain approvals in additional countries as required.
• Manage the relationships with external UK based partners responsible for the design, development, manufacture and testing of company products.
• To set and manage the budget for these activities.
• To advise the Technical Director on Quality and Regulatory matters
• The ideal candidate will be a self-motivated team player with the capability of working on their own when required.
• The company is currently a small team and outsources key activities therefore the position holder will have good inter-personal skills and be able to influence outside of line-management responsibilities.
Benefits include early progression to Quality Manager, stock options, opportunity to progress with a growing company that has a globally unique product that will make a real difference to the diagnosis of cancer