Remote Medical Device QMS Auditor (ISO 13485)

Computer Futures / SThree Group; Greater London; On-site; GBP 81,000 - 99,000; Full time

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Job summary

Computer Futures / SThree Group is seeking a Medical Device Auditor for a London-based role with remote working options. You will assess and improve Quality Management Systems for software-based medical devices, ensuring compliance with ISO 13485 and EU/UK MDR for QMS.

The ideal candidate has 4+ years in medical device auditing, solid experience with SaMD and risk-based auditing, and the ability to work across cross-functional teams in a regulated environment.

Qualifications

• 4+ years in medical device auditing
• Experience with ISO 13485 QMS auditing
• Knowledge of EU MDR/UK MDR for QMS
• SaMD/software auditing knowledge is a plus

Skills

Medical Device Industry Experience

ISO 13485 QMS Auditing/Management

EU MDR / UK MDR for QMS

Software & SaMD Expertise

Job description

Computer Futures / SThree Group is seeking a Medical Device Auditor for a London-based role with remote working options. You will assess and improve Quality Management Systems for software-based medical devices, ensuring compliance with ISO 13485 and EU/UK MDR for QMS.

The ideal candidate has 4+ years in medical device auditing, solid experience with SaMD and risk-based auditing, and the ability to work across cross-functional teams in a regulated environment.