Quality Engineer - £competitve salary + benefits - 4 day working week - Twickenham based

We have an exciting new role for a Quality Engineer to form part of this innovative and growing Biomedical Devices company. You will be joining an experienced team with the vision to grow the business worldwide. You will have the opportuninty to have a real impact by bringing new technology to new regions.

Main responsibilities will include the following:

• Quality Management – managing technical documentation, CAPA and writing/maintaining processes and procedures in compliance with ISO13485 QMS system. Verification and validation of ISO process and procedures.
• Management of the Technical Files.
• Risk Management File – maintenance and update of RMF in accordance with ISO14971.
• Active role in 3 new design projects including management of technical documentation in design process.
• Conduct internal audits and support external audits.
• Support on FDA registration for new products. Registration of products in different regions.
• Support the implementation and maintenance of the Post-Market Surveillance (PMS) system
• Collaborate with Purchasing to maintain a controlled list of approved critical suppliers, including risk classification.

Essential skills for the role:

• Degree in a Biomedical or Engineering-based discipline
• IT skills MS Office
• Must be fluent in written and spoken English to C1 level

Knowledge & Experience, Essential:

• Good understanding of reporting requirements under MDR/ISO-13485
• Minimum 3 years working in a quality role at a medical device company.

If you are looking for your next step within Engineering for a growing innovative company based in Twickenham please send your CV to the details provided. It is essential you meet the requirements to be shortlisted for the role. Salary dependent on experience.

Please be advised CVs will be treated in the strictest of confidence and that your application will not be forwarded without your permission. We aim to respond promptly to your application however, due to the high level of CVs we receive we are only able to respond to applicants whose profile matches our Clients requirements.