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 around software development, v&v expectations, and quality system.
requirements
* lead and support software verification and validation activities, including test‑method development, test strategy definition, automation opportunities, and readiness assessments for release.
* analyze software defect data, process metrics, and nonconformance trends to identify improvement opportunities and implement preventive measures.
* ensure proper execution of software change‑control processes, confirming changes are validated, documented, and compliant before release.
* validate software tools, automated test platforms, and data systems in accordance with quality system and regulatory requirements.
* provide technical guidance and mentorship to engineers and technicians across the quality organization, strengthening skills in software quality, documentation practices, and problem‑solving.
* bachelor’s degree is required in software engineering, electronic engineering, or biomedical engineering.
* 5+ years of experience in quality, regulatory, or compliance roles within the medical device, diagnostics, or life sciences industry.
* demonstrated success in regulatory authority interactions and external audits (fda, iso, eu mdr, or equivalent).
* strong understanding of global regulatory frameworks (fda qsr, iso 13485, eu mdr, mdsap).
* experience with iec 62304 (medical device software – software life cycle processes).
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