Quality Engineer 1 - Complaints

Location

Scotland, UK

Job Type

Company Overview

LumiraDx is a medical technology company developing, manufacturing and marketing smart connected diagnostics and diagnostic-led care solutions. Founded in 2014 by entrepreneurs with a successful track record in building and scaling medical diagnostics and health IT businesses, the company has major operations in the UK and the USA, and is supported by a global sales network, LumiraDx is a high growth organisation. We have recently launched the innovative LumiraDx Platform, and are looking for proactive, experienced, focused and enthusiastic individuals who can make a significant contribution to the continued growth and success of our dynamic and forward-looking company.

Role & Responsibilities

Quality Engineer 1 - Complaints - Multiple Opportunities

These positions could be based at either one of our facilities across Central Scotland

Role Description

Reporting to a Senior Quality or Quality Engineer, the successful candidate shall be responsible for providing support to the QA team in managing the day to day QMS activities associated with the production of IVD sensors (assays). Activities including but not exclusive to record reviews; coordination of documentation updates; archiving of quality records; coordination of corrective action closure and updating quality system information. Effective communication with LumiraDx personnel both within and outside of the Quality Department will be required.

Key Roles and Responsibilities

  • QA review of records including packaging batch records and raw material records
  • Working with internal personnel to facilitate closure of quality events, planned deviations, corrective actions and updating the relevant quality management systems
  • Contacting suppliers for compliance records
  • Coordination of quality documentation updates in the document control system
  • Archiving of quality records

Required Experience

About You:

Essential skills

  • Knowledge and experience of working in a role requiring attention to detail
  • Competent IT skills in EXCEL; POWERPOINT; WORD
  • Excellent attention to detail
  • Good interpersonal skills
  • • Good team worker
  • • Good organizational skills
  • • Self-starter

Desirable skills

  • Experience of working in a relevant quality assurance role within complaints
  • Knowledge and experience of ISO13485 or other quality management systems

 

For further information and to apply for this role, please click APPLY

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Thank you for your interest. If you're successful in your application, you may be subject to all or some of the LumiraDx standard pre-employment checks. This includes employment references; Criminal records data checks which are processed as part of our recruitment process for employment or continued employment to comply with legal and regulatory obligations to which the company is subject. LumiraDx place a high level of importance on its responsibilities for information security and privacy and have put in place an information security management system to ensure that the company and its staff maintain the highest standards with respect to data protection and information security.