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Job titleQuality Engineer
Job typeMeditech
Salary GBP
LocationUK South
Bonus Package
Job description

Are you an experienced Quality Engineer with a working knowledge of Quality Systems concepts? Do you want to work for a market leading medical devices company? A globally respected ophthalmology company with a rich history in the IOL space are looking for Quality Enginer to support new product introduction.
 

The company

Our client has worked closely with cataract surgeons throughout their history to lead the way in the innovation of IOLs and ophthalmic devices, making them key market player in the development of new IOL products and ocular therapeutics. Passionate about improving sight worldwide, they focus on achieving the very best in patient-care.

Their portfolio is broad and varied, including monofocal and premium IOLs, surgical devices and OSD solutions. This is supported by a strong Research and Development branch who are constantly working on developing new products using their extensive technical expertise.
 

The role

As a Quality Engineer you’ll be focused on new product introduction and ensuring their quality. You’ll work with a varied product portfolio and will be working on continuous process improvement and the reduction of defects. Working with the Quality team you’ll help to develop, implement and review quality controls in QA and Production departments to support new products development projects.

 

Responsibilities include:

  • Support the introduction of new products to market
  • Ensure continuous process improvement
  • Support defect reduction initiatives
  • Conducting Corrective and Preventative Actions (CAPA) investigations
  • Processing Nonconformity, Planned Deviations, and Supplier Activities
  • Acting as QA representative for product and process changes and validation protocols
  • Performing product release activities
  • Promoting a ‘quality culture’ in the business
  • Acting as a point of contact in supplier audits
  • Undertaking internal and external audits
  • Management of investigatory projects

 

The requirements

You will be an experienced Quality Engineer with experience with Quality Systems concepts and procedures, as well as…

  • Degree or equivalent experience in a science, clinical or engineering background
  • Strong track record in a Quality Engineering role
  • Knowledge of Quality System concepts and procedures (such as ISO:13485)
  • Previous use of databases and business management systems
  • Able to investigate complex issues and solve problems
  • Strong analytical skills
  • Ability to define root cause
  • Excellent written and verbal communication skills
  • Good people management skills and a track record of working as part of a multi-disciplinary team
  • Good IT literacy skills (including Microsoft applications)
  • Ambitious, with a passion for continuous improvement
  • Working knowledge of cGMP, FDA 21 CFR Part 820 QSR and ISO 13485 Medical Device Quality Management Systems desirable but not essential

 

Important information

FMC Contact for this role: Ryan Tosh (ryan.tosh@fmctalent.com)

Reference number: 8918

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Updated on 2017-08-07T17:04:38+00:00, by Matthew Graham.