Quality Assurance & Regulatory Engineer

Quality Assurance and Regulatory Engineer – Homebased
Opportunity:
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