What You’ll Deliver in the First 6–12 Months
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Take full QA ownership of one product family (Skin, Heart, Tissue) — running design controls, risk management, and change management in compliance with ISO 13485, EU MDR, and FDA requirements.
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Clear the backlog of open Medical Device Changes and establish a functioning change control cadence that keeps pace with the engineering team.
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Embed QA into all relevant Engineering Epics — no product development running without active QA coverage.
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Deliver an audit-ready design history file and technical documentation for your assigned product family.
Lead risk management activities in accordance with ISO 14971 — identifying, evaluating, and controlling risks with a pragmatic, engineering-driven approach.
Own the full risk management lifecycle for your product family, from hazard identification through residual risk evaluation and benefit-risk analysis.
Drive design controls across the product lifecycle.
Including verification and validation strategy, design reviews, design inputs and outputs, and traceability throughout.
Ensure design changes are properly assessed, documented, reviewed, and approved in compliance with applicable regulations and internal procedures.
Coordinate design transfer.
Work closely with manufacturing QA Lead and Production
Support technical documentation for regulatory submissions.
Including Design History Files and Technical Documentation under EU MDR.
Lead continuous improvement initiatives.
Leveraging modern QA tooling, AI-assisted documentation, and automated testing frameworks to improve quality, compliance, and development speed.
Act as QA subject matter expert for internal and external audits.
Covering medical device design quality, design controls, and design transfer.
Participate in post-market surveillance.
Identify design-related issues and coordinate corrective and preventive actions.