Quality Specialist - West Midlands

Recruiter
X4 Group
Location
Warwickshire
Salary
£30,000 per annum
Posted
27 Jul 2017
Closes
31 Aug 2017
Sector
General
Contract Type
Full Time

Quality Specialist / Career Progression / QA Specialist / Quality Assurance Specialist

Location: West Midlands

Salary: Circa £35,000 plus benefits (potentially flexible for someone more experienced

A West Midlands based Medical Device Manufacturer are seeking a Quality Specialist to join their team on a permanent basis. This role will have a development path to grow and expand within the organisation and lead into management.

It is a well suited role for someone looking for that opportunity to have outlined progression which is quite often not available or mapped out within a company.

Role and Responsibilities:

  • Carrying Out internal audits
  • Providing compliance expertise to design teams
  • Compilation of design history files & technical files
  • Defining the appropriate level of verification and validation testing and compiling test results into summary reports
  • Managing product risk management process through all lifecycle activities
  • Co-ordination of new product compliance test activities including coordinating of external test facilities
  • Capturing product changes and/or improvements through quality processes and ensuring product technical files remain robust
  • Driving timely and appropriate closure of CAPA
  • Manage product quality issues, defining & coordinating corrective & preventive action plans through to resolution
  • Involvement in design verification & validation, generating of summary reports for inclusion in technical files

Required experience:

  • Experienced in overseeing change control, quality issues and CAPA
  • Working knowledge of ISO 13485 & ISO 9001
  • Compliance with Internal & External Quality Audits
  • Compiling technical files to support CE & FDA submission

Apply ASAP as interviews can be arranged for the end of this week. Send your updated CV through to and call Renee on to discuss further.

ISO 13485 / Medical Devices / CAPA / Technical Files / ISO 9001 / Validation / CE Marking / FDA