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Senior Quality Systems Engineer

Quality Start
Job LocationBrownhills, Walsall
EducationNot Mentioned
Salary43.17 per hour
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypeContract , full-time Work from home3 Months Contract

Job Description

Senior Quality Systems Engineer -HomebasedOpportunity:Are you currentlyupgrading Quality Management Systems to transition to the new MDR regulation Do you have experience in dealing with NC/CAPA and of change control documentation Have you drafted/customised and implemented 3rd and 4th tier documentation(work instructions and templates/forms) Looking for your next contract role based working from home with an exciting global medical device company If yes then this is the role for you.Your role as a Senior Quality Systems Engineerbased working from home will involve being part of the team of upgrading the companies QMS to transition to the MDR and to address the effectiveness of key systems.You will deal with the backlogs of NC/CAPA and of change control documentation. You will also support in drafting/customising and implementing 3rd and 4th tier documentation (work instructions and templates/forms).The focus on the role is for the following specific tasks:

  • Co-ordinating the progress of open NC/CAPA to closure by liaising with process owners.
  • Co-ordinating the completion of documentation and closure of open change requests by liaising with process owners.
  • Reporting on the progress of clearance of backlogs to management.
  • Supporting the Head of QA/RA in the remediation of QMS documentation for compliance with incorporated requirements and transition to MDR.
  • Communicating with External Suppliers to address matters of quality or compliance.
  • Supporting of the companies training system.
  • Providing support during and prior to regulatory audits.
  • Direct writing and review of company procedures, forms and work instructions to ensure compliance, efficiency and clarity.
This is a 3 months contract role which will be reviewed for a possible extension or go permanent but everything is dependent on the individual and business performance. There will be occasional travel to their site in Brownhills, West Midlands as and whenneeded.The PAYE rate is £43.17 per hour.Skills:To apply for the role ofSenior Quality Systems Engineeryou will have the following:
  • Experienced senior quality systems engineer with medical device experience (essential), preferably with electromechanical devices or higher risk devices.
  • MDR training and experience is held internally so MDR experience is not essential. It would be a good opportunity for a quality professional who does not have this to pick it up.
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 dont 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 :
Change ControlMedical DevicesQuality AssuranceQuality SystemCAPAs

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