We are working with a global Medical Device company who, due to their exceptional continued growth, have an exciting opportunity for a Quality System Specialist - Training and Compliance to join the team in Reading in a primarily remote position.

As our new Quality System Specialist - Training and Compliance your role will be to both provide and ensure all new starters complete all training relating to the company QMS and QA, standards and regulations as well as ensuring all existing staff have completed any updated training across the business for QMS, regulations and standards. Your role will also be to provide compliance and QMS support to ISO 13485, ISO 9001, MDSAP, CFR 820 and CE Certification. 

This is a fantastic opportunity for an experienced Quality Assurance/Quality Systems professional from the Medical Device sector who is looking for a diverse role with a clear career and training progression pathway. 

 Key responsibilities will include:

• QMS – implementation of trainings requirements and supporting documentation, translations and SharePoint.
• Providing compliance support related to FDA CFR820 MDSAP, ISO13485:2016 and ISO9001:2015 as well CE Certification.
• Internal training administration and escalations.

Experience, Education and Knowledge Required:

• Proven experience in a Quality System/Compliance role within the Medical Device sector
• Strong knowledge of ISO 13485, FDA CFR 820, ISO 9001 and MDD/MDR.
• Knowledge and experience of working with SAP Document Management.
• Understanding and awareness of MDSAP (Desirable)

If you have the necessary skills and experience to be successful as our Quality System Specialist - Training and Compliance and want to join a company passionate about your progression, click apply now or call 01189 239 234 and ask for Kris Holmes.