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Quality and Regulatory Systems Engineer

Quality Start
Job LocationBirmingham
EducationNot Mentioned
Salary£40,000 - £45,000 per annum, negotiable
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time Work from home

Job Description

Quality and Regulatory Systems Engineer - HomebasedOpportunity:Are you currently working as a quality and regulatory engineer looking for your next role Have you implemented or maintained a quality management system Do you have experience in dealing with NCR/CAPA’s and change controls Looking for your next contractrole based working from home with an exciting global medical device company If yes then this is the role for you.Your role as a Quality and Regulatory Systems Engineer based working from home will involve supporting the QA/RA department and working with all other departments to secure and maintain quality & regulatory compliance across the medical device product range.Duties and responsibilities include:

  • NCR/CAPA- Root cause analysis, monitoring of open NCR/CAPA’s.
  • Change control - Monitoring of open change control, raising new change control.
  • EQMS- Performing document control activities, including creating, distributing, modifying, storing and reviewing documents and records.
  • Post-Market Surveillance activities: Assisting with PMCF plans, PMS data collection, analysis and reporting.
  • Supporting the registration of new products for UK, EU & ROW.
  • Managing product vigilance issues, including field safety notices, customer advisory notices and liaison with National Competent Authorities as required.
  • Risk Management of medical devices.
  • Software validation - Writing test cases/executing test cases.
  • Supplier quality assurance development.
This is a full time permanent job opportunity paying an excellent salary of £40,000 - £45,000 per annum plus great benefits. The role is based working from home and to attend the site in Walsall, West Midlands approx 2-3 times every fortnight and as andwhen required.Skills:To apply for the role of Quality and Regulatory Systems Engineer you will have the following:
  • Minimum of a bachelor’s degree, preferably in a science or engineering field.
  • Experience in quality system standards and regulation, e.g., ISO 13485, 21 CFR 820, MDD and MDR.
  • Experience working in a manufacturing facility, ideally electro medical (flexible).
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 forreferring 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 www.qualitystart.co.ukIf 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.

Keyskills :
CAPAMedical DevicesQuality AssuranceRisk ManagementQuality System

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