Quality Engineer QMS, Jobs, 6406

Engineering, Manufacturing & Supply Chain Recruitment

Quality Engineer - QMS - Stirling & Falkirk

Engineering & Manufacturing - Engineering & Manufacturing
Ref: 6406 Date Posted: Friday 29 Nov 2019
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Nine Twenty Engineering & Manufacturing are delighted to be representing our Stirling-based Manufacturing client in their search for a number of Quality Engineer to join the team on a Permanent basis.

This opportunity presents the chance for an upbeat and proactive individual to join a dynamic company to make a real contribution to the continuing growth and success of the organisation as well as putting a strong emphasis on personal development.

Excellent remuneration on offer. 

We are looking for someone with preferably a medical device, pharmaceutical or scientific background.

Key Role and Responsibilities

  • Batch record review and product release
  • Device Master Record updates
  • Review of non conformances, planned deviations and change controls
  • Prepare and create documents and records for upload on to documentation management system
  • Internal auditor
  • Identify and implement improvements in LumiraDx QMS
  • Interact with all areas of the organization to ensure that quality processes and procedures are embedded

Essential skills

  • Experience of batch record (or equivalent quality record) review
  • Experience of coordination and QA review of non-conformances and planned deviations
  • Experience of working with quality systems and processes (eg audit, non-conformance, CAPA, change control)
  • Knowledge and experience of working to the quality and regulatory standards in a medical device, pharmaceutical or similar manufacturing industry with a proven track record in a relevant role
  • Experience of working in a dynamic fast-paced environment
  • Ability to use problem-solving tools and methodologies
  • Influence internal team and external parties to maximize success opportunities

Desirable skills

  • Knowledge and experience of working in a quality assurance role in medical devices and of the quality and regulatory standards ISO13485, FDA 21CFR Part 820.  
  • Trained auditor
  • Knowledge and experience in immunoassays and molecular assays
  • Continual Improvement mindset (PDCA, Kaizen, Six Sigma, Lean, Value Stream Mapping)