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Job Description
- Run the Quality Management System (QMS) process, ensuring evidence collection and control to meet statutory and regulatory requirements.
- Maintain a state of 'inspection readiness' through proactive evidence collection.
- Administer the evidence control system and associated processes.
- Coordinate logistics for external regulatory inspections and third-party audits to provide necessary evidence as required by auditors and inspectors.
- Collaborate with Engineering to translate contemporary technical workflows, such as code submissions and automated checks, into rigorous SaMD compliance evidence to support regulatory expectations.