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Careers


JOIN A TEAM OF WORLD LEADING EXPERTS

SENIOR QUALITY MANAGER

A Senior Quality Manager is needed to proactively ensure that SIME Dx’s processes and procedures follow appropriate national and international regulatory compliance guidelines. The successful candidate will be based in London with the commercial team and will advise the Management Team on applying QM effectively throughout the product lifecycle.

Job duties include:

  • Managing the Regulatory Pathway project 
  • Directing internal/external audits processes
  • Overseeing device calibration and preventative maintenance program
  • Maintenance of the FDA pre-submission dossier
  • Maintenance of the Quality Management System (QMS)
  • Managing relationships with external regulatory consultancies
  • Establishing and maintaining software development documentation

Required experience:

  • Minimum 3 years Quality Management experience with commercial medical devices
  • Auditor certification
  • ISO 13485, ISO 14971, IEC 62304, IEC 60601-1 and IEC 62366 standards
  • Excellent communication and interpersonal skills


SENIOR MEDICAL DEVICE SOFTWARE ENGINEER

An experienced senior Medical Device software engineer is needed to join our London-based commercial team reporting to the COO. The successful candidate will be responsible for engineering a Windows C# application client and server database which integrates to an IVD device (non-embedded).

We are implementing a Quality Management System (QMS) following ISO 13485, a software development process following IEC 62304 and IEC 60601-1, and security following ISO 27001. Experience in software engineering to regulatory compliance guidelines in general and the above standards in particular would therefore be a prerequisite.

Required experience:

  • Degree in Computer Science, Physical/Life Science, Engineering or equivalent at minimum BSc level
  • Minimum 5 years commercial medical device software development lifecycle including software documentation creation and source code management
  • SQL Server
  • Microsoft Visual Studio
  • Windows Component Object Model (COM)
  • Proven team player
  • Able to meet tight deadlines
  • Excellent interpersonal and communication skills

Desirable experience:

  • System Architecture
  • Microsoft Azure Cloud development
  • HL7
  • Audit trail development
  • Electronic Medical Records

For more information, or to apply please send us a cover letter and C.V. to INFO@simedx.com