Quality Assurance and Regulatory Engineer – HomebasedOpportunity:Do you have experience in quality assurance and regulatory affairs for medical devices? Do you have experience of working to ISO 13485, ISO 14971 and UK MDR, Regulation (EU) 2017/745, MDSAP, ISO 9001 standards? Want to work for an innovative medical device manufacturing company? If yes then this is the role for you.Your role as a Quality Assurance and Regulatory Engineer will involve:Supplier & Purchasing: * Reviewing the supplier onboarding, supplier revaluation and purchasing processes to ensure compliance with specific country regulations. * Creating new documents to support the supplier and purchasing processes. * Establishing controls for critical suppliers. * Creating supplier quality agreements.Labelling * Reviewing product and software labelling and conducting a gap analysis to ensure labels meet all regulatory and compliance standards.Risk Management * Supporting product risk management activities according to current procedures. * Reviewing all processes within the quality management system and document process risks in accordance with ISO 14971.Trend Analysis * Establishing a process to collect, analyse and report on quality data to identify trends and areas for improvement.Training * Creating training material on relevant regulations, standards, and guidance (e.g. UK MDR, Regulation (EU) 2017/745, MDSAP, ISO9001).Regulatory:Supporting the QARA team in: * Creating a documentation pack aligned to the IMDRF table of contents to support registration of medical devices within Europe, Canada, Australia and the rest of the world. * Maintaining and archiving technical documentation and regulatory files, including the regular review and updates required to ensure ongoing compliance with current standards and legal requirements. * Preparing and compiling reports necessary for regulatory compliance, including monthly quality reports.This is a 6 Months Contract role based working from home. You will attend the office at Walsall, West Midlands approx. 2 days every fortnight.The client will review the contract towards the end date with a view of extending it or making the role permanent however this is all dependent on the individual and business performance.The PAYE rate is between £28.00 - £41.19 per hour. This is purely dependent on skills and experience.Skills:To apply for the role of Quality Assurance and Regulatory Engineer you will have the following: * Proven experience in quality assurance and regulatory affairs within the medical device sector. * Strong analytical and problem-solving skills. * Confident, professional, and comfortable working in a close-knit team environment. * Working knowledge of international medical device regulations, standards, and guidance documents including MDSAP, Regulation (EU) 2017/745, ISO 13485, ISO 9001 and ISO 14971. * Competence in the use of QMS and IT tools, including MS Office, SharePoint, MS Teams, Word, Excel and Outlook.How to Apply:To apply for this one off opportunity, please send a word copy of your CV to me now by clicking on the Apply button or call me for a confidential chat. Please ensure you have read and agree to our Privacy Policy which can be found on the Quality Start website.If this sounds like the role for you or a colleague then please don’t hesitate to contact us. If we manage to successfully fill a permanent placement from your recommendation then we will send you a cheque of £300. We also have many incentive schemes for referring contractors/temp staff so please contact us with the referral and we can provide you with more information.For a list of our current vacancies, please visit the Quality Start website.If you do not hear from Quality Start within 2 weeks your CV has not been short listed for this role.Quality Start are acting as a specialist recruitment consultancy for this role