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  • Location: Oxford, Oxfordshire, England
  • Salary: Competitive Salary with Benefits
  • Job Type:Permanent

Posted 8 days ago

  • Sector: Quality, MedTech, Medical
  • Contact: Cameron Miskin
  • Contact Email: cameron.miskin@nextphaserecruitment.com
  • Contact Phone: 01403 216216
  • Start Date: 2021-09-09
  • Job Ref: V-47007
Are you looking to work for a company that makes a genuine difference to the world? Do you have expertise in ISO13485 Quality Management Systems? An exciting role for a forward thinking QMS Co-ordinator has become available with an innovative biotech organisation on the outskirts of Oxford. Specialising in molecular diagnostics and the detection of early-stage cancers, they are striving to change lives through earlier and smarter answers across the cancer journey.  
 
This is a permanent role, paying a very generous salary and benefits (to discuss on application). 
 
As the QMS Coordinator you will have the ability to support the implementation and maintenance of an integrated QMS that meets the requirements of ISO13485. You will train employees in QMS procedures, alongside conducting audits to improve effectiveness and compliance standards. You will have the ability to work across internal departments which involves providing the QA team resource for daily administrative requirements of the quality management system including CAPA, document control, and record keeping. 
 
Other Responsibilities & Skills 
  • Assist in the design of training programmes for QMS procedure implementation. 
  • Train employees companywide in QMS procedures owned by QA. 
  • Audit the implementation of QMS procedures for compliance and effectiveness. 
  • Revise processes in line with audit findings. 
  • Promote an understanding of the role of Quality in a business context. 
  • Make presentations to different audiences. 
  • Operate electronic QMS systems (including document control). 
  • Competent in word processing, spreadsheets, databases. 
  • Communication with sub-contract organizations. 
 
Qualifications and Experience Required  
 
  • Quality systems auditing experience (ideally with IRCA accreditation) 
  • 3+ years hands-on experience supporting the development, operation, and maintenance of a ISO13485 structured quality management system
  • Basic understanding of 21 CFR Part 820 preferred. 
  • Excellent communication skills and the ability to build strong, collaborative relationships with people at all levels.