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Job Title: Engineer II, Quality Management System

LumiraDx UK Ltd
Bathgate, ND Other
POSTED ON 4/5/2024

This role is Maternity cover: 12 Month Contract

 

Job Purpose:



Reporting to the LumiraDx Quality Lead, the successful candidate shall be accountable for maintaining compliance of the LumiraDx Stirling Quality Management System, input into the management of complaints and post-market activities ensuring that the requirements of ISO 13485:2016, CFR 21 Part 820 IVDD/IVDR are adhered to in full.


Scope of role:


The successful candidate shall be responsible for carrying out day-to-day Quality Management Systems and post market activities associated with the LumiraDx on-market product.  Activities such as document creation and review, input into and performing investigations, vigilance reporting and maintenance of trend analysis are requirements of this role. Effective cross-functional within the business is key to the role.


Responsibilities:

  • Performing routine QMS activities associated with post market vigilance and complaints to meet the wider business goals.
  • Prepare and create documents and records for upload on to the document management system
  • Review and approve returned product evaluations
  • Performing data and trend analysis, providing input to investigations and generation of KPIs
  • Continual development of QMS processes and procedures driving lean practices throughout the team
  • Providing QA input to investigations supporting timely completion and resolution

Quality / Regulatory Compliance

  • Maintaining compliance of the QMS
  • Ensuring timely completion of post market and vigilance related activities
  • Support and input to internal / external audits

Hourly Wage Estimation for Job Title: Engineer II, Quality Management System in Bathgate, ND
$40.59 to $51.30
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