Management Systems Engineer / Quality Engineer / Quality Assurance / Medical Devices

Kingswinford, West Midlands
22 Aug 2018
19 Sep 2018
Contract Type
Full Time


Management Systems Engineer / Quality Engineer / Quality Assurance / Medical Devices  
Kingswinford, Dudley Commutable from Birmingham and Wolverhampton

Our client is committed to providing safe and reliable equipment for people with reduced mobility, and those who care for them, to help make their everyday life easier.

They are currently recruiting for a Management Systems Engineer to join the Quality team, organising and heading up the day to day management of the company’s quality system, working to various ISO, OHSAS and FDA QSR standard requirements. Maintaining certification to these standards you’ll manage the administration of the management system, driving actions and supporting colleagues to ensure compliance.
Within this role your key responsibilities will include liaising with external certification bodies, lead and implementing the internal audit programme for QHSE, conducting internal audits and driving improvements. As a Management Systems Engineer you’ll also represent the company and report on system and product certification audits and will implement and manage Group QHSE policies and Procedures and all QHSE documentation. Further tasks will include updating the NC Log with actions resulting from internal audits, third party audits and other non-conformances and if necessary escalating to CAPA. Taking responsibility for DHR sign off and autorisation you’ll file the DHR records ensuring that in the event of a regulatory audit or recall activity documents are easy to locate.

Our client is looking for someone with medical device regulatory experience and/or qualification/s, with a recognised quality qualification and/or membership of professional body, for example. CQI. You’ll have auditing experience in any of the following; ISO 9001, ISO 45001, ISO 14001, ISO 13485 and FDA Part 820 Quality Systems Regulation- ideally lead auditor trained. With experience of working within a regulated industry you will have knowledge of ISO 9001 and quality systems knowledge relating to medical devices. We are welcoming applications from candidates with strong data management experience with excellent IT skills and the ability to analyse and interpret “big data”  and produce reports.

Please note this role may involve some EU or Worldwide travel so a flexible approach to working hours is essential.