About the Role
Responsibilities
- Lead software quality engineering activities across the full product lifecycle, ensuring compliance with ISO 13485, FDA QSRs, IEC 62304, ISO 14971, and relevant cybersecurity and data‑protection requirements.
- Develop, review, and approve software quality documentation, including validation plans, protocols, reports, requirements traceability, verification/validation evidence, and risk‑management documentation.
- Drive software‑related risk management activities, including identification of hazards, evaluation of risk mitigations, and verification of risk control effectiveness.
- Lead complex investigations using advanced root‑cause analysis, data analytics, and statistical methods to identify systemic trends, prevent recurrence, and drive corrective and preventive actions (CAPA).
- Partner closely with global Software Engineering, Systems Engineering, Product Security, Regulatory, and Clinical teams to ensure alignment...
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