Job Description
We’re an early-stage medical device company (preferably seeking diagnostics/IVD experience) looking for an hourly QA consultant/contractor to guide our team and help review/build our quality documentation as we set up strong fundamentals from the start. This is a hands-on, collaborative role - working with us to shape, improve, and verify the right docs and processes.
What you’ll do:
Review and help develop QMS documentation (SOPs, templates, records)
Guide document control, training records, and change control practices
Support design controls (requirements, DHF structure, design reviews)
Assist with risk management (ISO 14971), CAPA/NCR basics, and supplier quality as needed
Provide practical QA mentorship to keep us aligned with ISO 13485 / 21 CFR 820
Preferred background:
Medical device QA experience; diagnostics/IVD/POC strongly preferred
Familiar with ISO 13485, 21 CFR 820, and structured documentation systems
Strong reviewer/editor—able to translate requirements into clean, usable documentation
Startup/early-stage build-out experience is a plus
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