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Quality Manager - Assay Development

Job LocationMotherwell
EducationNot Mentioned
Salary50,000 - 60,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

Our client is a global medical device company developing and marketing smart connected diagnostics and IVDs. The company has major operations in the UK and internationally and is experiencing rapid growth.Position:The Quality Manager - Assay Development will be responsible for the quality and regulatory activities associated with IVD assays and Quality Controls through the design and development, verification and validation, transfer to manufacturing, and releaseand post-market phases of Assays. The Quality Manager - Assay Development shall be responsible for line managing the development quality engineer group associated with IVD assay development through the R&D phase and the verification and validation phase. Therole holder shall also work cross-functionally with other teams.Responsibilities:

  • Line Manage the Development Quality Engineers
  • Creation and management of the IVDR 2017/746 CE marking Technical files
  • Update IVDD 98/79/EC Technical Files to comply with IVDR 2017/746
  • Manage change control impacting CE marking Technical Files and other regulatory submissions
  • Ensure that clinical performance evaluations are conducted appropriately to fulfill the requirements of IVDR 2017/746 for Notified Body submission for CE marking and other global regulatory submissions
  • Ensure that all Risk Management activities are conducted appropriately to fulfill the requirements of IVDR 2017/746 for Notified Body submission for CE marking and other global regulatory submissions
  • Support the assay verification and validation activities-reviewing and approving protocols
  • Support the transfer of product from R&D to manufacture
  • Work with individual assay development teams as a quality and regulatory support
  • Work with the Technical Leaders and Project Managers to maintain quality throughout the Design and Development process
  • Introduce new organisational skills and problem-solving methodologies into the Development Quality Engineer group to enable the group to launch multiple successful assays
Skills:
  • Knowledge of working to the appropriate quality and regulatory standards including ISO13485, FDA 21CFR Part 820.
  • IVD or medical device environment with a quality focus and development, verification and validation activities.
  • Post-launch IVD or medical device activities
  • Scientific background, or Educated in a relevant field.
To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England andWales

Keyskills :
AuditManufacturingRisk ManagementIVDISO 13485quality assurancemedical deviceAssay

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