QA Engineer

• Play critical role at intersection of product development, quality assurance, and regulatory compliance.
• Lead QARA workstreams aligned to product lifecycle (PLM); ensure safety, quality, regulatory readiness of DeepHealth's medical device software and digital health solutions.
• Lead QARA integration across design controls, risk management, verification/validation (V&V), and design transfer phases.
• Partner with Regulatory Affairs to support audits, gap assessments, and regulatory submissions (FDA 510(k), CE Mark, etc.).
• Analyze quality events, lead root cause investigations, and drive CAPA implementation and closure.
• Champion continuous improvement using Lean Six Sigma; reduce defects and streamline compliance workflows.
• Serve as QARA lead for product development initiatives; ensure alignment with phase-gate milestones.
• Facilitate coordination between engineering, clinical, regulatory, and QA to resolve blockers and meet program targets.
• Provide updates to PMO and executive stakeholders on quality status, risks, and dependencies.
• Remote role with ~5-10% travel; US-only remote with multiple US city options.

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