Quality Trainer / Consultant (ISO 9001 Quality Management Systems)
Consultant – Medical Device Quality and Regulatory
QCS International, part of the PHSC plc Group of Companies, is a leading provider of a wide range of training, consultancy and outsourced services to clients throughout the world. We install management systems to ISO 9001, ISO14001, ISO 45001 & ISO 13485, and, within the medical device sector, undertake work on CE Marking, FDA applications, auditing services, systems management and UK Responsible Person Services.
Recent growth in our UK Responsible Person services for businesses located outside the UK has resulted in the need for a new consultant with specialism in the medical device sector. This post requires the successful candidate to have a practical working knowledge of medical devices, the regulatory framework relevant to product development and quality management in the medical device sector.
This post is ideally suited to a quality or regulatory associate in the medical device sector who may have 2- or three-years’ experience and who is now ready to expand their knowledge and exposure to a wider range of product types and services. Whilst work will begin on UKRP services we plan to develop the appointed consultant to widen their experience and knowledge on the regulatory framework, ISO 13485, auditing and, eventually training services.
This is a new and exciting opportunity for a medical device specialist to expand their contacts, broaden their experience and become an active and vital member of staff within our small medical device team.
The successful candidate must have:
- A degree or equivalent in a scientific or engineering discipline.
- Work experience in the medical device sector
- Some knowledge and understanding of the regulatory framework for medical devices in the UK, EU and beyond
- A full UK driving licence
It would be useful, but not essential to also
- Have experience implementing, using and can demonstrate knowledge of ISO13485 (a knowledge of ISO9001 is also an advantage)
- Be adaptable and able to apply analytical skills in diverse situations
- Be dynamic with a strong customer focus, exceptional communication and computing skills
- Experience with auditing
- Experience in Product Conformity Documentation, i.e. CE Marking or FDA Applications
- The ability to speak a European language.
The post can involve travel to locations throughout the UK and abroad. QCS are taking a flexible approach to this position and will consider part-time and full-time options
Remuneration will be commensurate with experience.
Please apply by submitting your CV with covering letter (with salary expectation if relevant) to Audrey Smith, Training Sales Director, email@example.com. Learn more about our company on our website – www.qcsl.co.uk