Quality Engineer / Senior QE - Medical Devices - Hampshire

Quality Assurance - Devices - Quality Engineer
Ref: 20 Date Posted: Thursday 12 Sep 2019
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Senior Quality Engineer

Up to circa £55k

North Hampshire

Medical Devices (active)

 

Our client is an established medical device company based in North Hampshire – easily assessable from the M3.

 

They are looking to secure a permanent Senior QE / Quality Engineer.

 

Our client is an established medical device company with a 15 year history and a market leading active (electronic/software) medical device sold in UK, Europe, US and beyond.

 

They have had huge investment to expand their product sales on a truly global scale and are looking to hire the services of a permanent Senior Quality Engineer / QE to assist in supporting this growth.

 

This is a fantastic opportunity to join a very successful company at an exciting time – our client has an excellent product and is financially strong offering a stable base for career enhancement as well as the opportunity to join a dynamic and growing QA/RA team.

 

They offer a highly competitive salary base as well as an industry leading benefits package and training initiatives.

 

This position will suit an already established senior level Quality Engineer or someone looking to take a step up into a senior QE role – strong med tech industry / ISO 13485 experience is essential.

 

Please apply today or contact the Medical Device Team at Indo Professionals today. josh@indoprofessionals.co.uk / 01256 597 800.

 

Job title:

Senior Quality Engineer (Snr QE)

 

Salary:

Up to circa £55,000 per annum (candidates seeking more or less will also be considered)

Benefits package includes bonus, contributory pension, healthcare, training

 

Location:

North Hampshire – close to the M3

Assessable from Hampshire, Surrey, Berkshire, South Oxfordshire, parts of Wiltshire and South London

 

Job role:

Reporting to the Quality Assurance Manager, the successful Senior Quality Engineer / QE applicant will be providing support for all quality activities. Within this role the focus will be;

  • Provision of support in the management of customer complaints
  • Support CAPA management
  • QMS performance review and input into improvements / changes
  • Action issues arising from audits, complaints and nonconformities and identify opportunities for preventing and correcting further problems
  • Provision of quality input into new product development and manufacturing activities
  • Support calibration of R&D, test and manufacturing equipment
  • Assist technical team in all quality matters relating to design, manufacture, suppliers and distribution of all medical devices
  • Support management of suppliers
  • Support all returns, complaints and post-market issues
  • Support management with development of the Quality Program Plan and on-going maintenance
  • Investigate product quality issues, determine root cause, analyse data and implement corrective actions
  • Assist in records management and document control
  • Support production activities from a quality perspective
  • Support validation testing
  • Perform internal audits
  • Perform supplier audits
  • Assist in development and delivery of internal quality training

 

Experience required:

  • Experience in a quality engineering within medical devices – essential  
  • Experience of electronic medical devices – advantageous
  • Experience managing supplier quality performance / supplier management experience
  • Experience in fault finding/investigation
  • Experience of working within a QMS driven environment
  • Hands-on experience of implementing procedural changes
  • Experience of working to ISO900/ISO 13485
  • Excellent written English and report writing skills
  • Experience / understanding of FDA requirements (CFR 820) would be advantageous
  • Excellent communication and presentation skills

Job reference:

J-0015

 

Indo Professionals is a specialist medical device staffing business focused on placing high calibre professionals into regulatory affairs, quality assurance and clinical research positions UK wide. If you are looking for a new career challenge or would like a career consultation with an industry expert, please contact the team today.