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QA/RA Officer

Equals One
Job LocationManchester
EducationNot Mentioned
SalarySalary negotiable
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

QA/RA OfficerSalary dependent on experienceFull time, PermanentManchester, M13 9XXOur Genedrive® device is a rapid, versatile, simple-to-use and robust point-of-need molecular diagnostics platform for use in patient stratification of patients (genotyping), pathogen detection and other clinical indications such as infectious disease detection.Job summaryThe QA/RA Officer will support the Director of Quality & Regulatory Affairs by assisting in maintaining an appropriate quality environment for the development and manufacture of products that meet the requirements of European and other Regulators as theCompany moves towards becoming a leading clinical diagnostics company. The role is split predominately 70% quality and 30% regulatory.Essential Functions

  • Participate fully as a member of the Quality Team within and across the business.
  • Provide Quality and Regulatory support to all departments within the business.
  • Collaborate with internal and external stakeholders to ensure all our processes comply with the relevant standards and regulations.
  • Collate and provide KPI’s, trend data and statistical analysis for Management Review and any other review boards where requested.
  • Provide guidance on Risk Management activities.
  • Provide guidance, support and maintain the Non-Conformance/Deviation system.
  • Provide guidance and perform Root Cause Analysis into CAPA investigations.
  • Assist in the review of Technical, Medical Device and Design History Files.
  • Create, review, advise and provide guidance on interpretation of SOP’s.
  • Review, advise and provide guidance on interpretation of Regulatory requirements.
  • Review Verification and Validation Data Reports and SOP’s and provide support during the Validation activities.
  • Provide assistance with the maintenance of the electronic and hardcopy record archives.
  • Perform internal Audits to a predefined schedule
  • Participate and support in external Inspections and Audits with clients, distributors and Notified Bodies.
  • Perform other appropriate duties as assigned.
  • Provide support and guidance for new product development projects.
Knowledge, skills and abilities required:
  • Attention to detail.
  • Ideally possess experience from a manufacturing/quality environment
  • Medical device experience desirable
  • Organisational and prioritisation skills.
  • Strong written and verbal communication skills.
  • Problem solving.
Job description:
  • Ability to work alone
  • Ability to work as part of a team.
  • Working knowledge of ISO 13485.
Other
  • BSc in a Biological Science based degree.
  • Proven experience (3 years or more) of working in Quality Assurance in the IVD or Medical Device Industry
Interested in the QA/RA Officer role Please apply with your updated CV.IND1

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