Location:

Midlands

Qualifications:

Degree

Experience:

3-4 Years

Job Type:

Contract

Salary:

40-50,000

Consultant:

James Cassidy +353 1 685 45 45

QA/RA Engineer - Medical Device

Technical QA/RA Engineer - Medical Device


Profile:

Our client is a global multinational Medical Device manufacturer and they are seeking a Technical QA/RA engineer with excellent attention to detail and technical writing ability to join the team as part of a global technical file management audit project. This is a 2 year fixed term contract position with a view to extension.


Job Purpose:

The successful candidate will develop specifications and inspection criteria, create and update the QA documentations and instructions in line with the Medical Devices Directive and ensure the company is positioned at all times as a key preferred supplier within the medical device space.


Key Responsibilities:

Apply technical solutions to problem solving
Apply technical solutions to quality improvement projects
Use technical writing skills to clearly describe technical information
Analyze customer complaints, identify trends and execute corrective actions
Understand standards and their application to medical devices
Planning, protocol generation, testing and report generation for medical devices
Generation and maintenance of technical files for medical devices
Review and update technical files in line with EU medical devices regulatory requirements
The use of GHTF STED format and harmonised standards when compiling a technical file in compliance with the MDD
Ensuring that records are filed in accordance with site procedures
Supporting R&D


Essential Skills / Experience:

Engineering / Science qualification
3/4 years experience within R&D / QA/ RA/ Compliance or Validation function in a Medical Device Environment
Excellent technical writing experience within a medical device environment
2/3 years experience in Risk, Clinical and Biocompatibility an advantage
Fluency in English
Good knowledge of the Medical Device Directive.
Attention to detail and accuracy
Ability to work well under deadlines and pressure
Problem solving skills for developing creative solutions and meeting objectives are required.
Skills that enable coordination of data, including MS-Office (primarily PowerPoint, Word, MD Project, Outlook and Excel);
Excellent analytical ability
The ability to prioritize tasks and be able to manage several projects and tasks simultaneously; and the ability to interface with all levels of management.


Behaviours and Values:

Approachable, enthusiastic, flexible and adaptable.
Ability and Willingness to Travel to Europe and Far East
Ability to work on own initiative, self starter and team player
Good organisational skills and cultural awareness and sensitivity
Good judgement and problem solving ability

Contact for further details:

James Cassidy on +353 1 685 45 45

For Immediate Consideration Please Apply Online Now