Senior Quality Engineer In Vitro Diagnostics
Core
Senior subject matter expert ensuring quality, safety, and regulatory compliance of In Vitro Diagnostics (IVD) across the full product lifecycle from development to commercialization.
Role type
Senior IC Quality Engineer (IVD)
Builds
IVD products and compliant quality management systems
Domain
Healthcare / In Vitro Diagnostics / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
IVD QMS design and implementation, EU IVDR and FDA 21 CFR Part 809/812/820 compliance, ISO 13485/18113/15189 standards, design controls, analytical validation, clinical performance evaluation, risk management (ISO 14971), supplier qualification, post-market surveillance, CAPA management
Preferred skills
Advanced degree (MS/PhD), leadership experience, assay development and validation, laboratory quality systems implementation, clinical study support, drug-device combination products knowledge, SaMD quality considerations
Technologies
ISO 13485, EU IVDR, FDA 21 CFR Part 809/812/820, ISO 18113, ISO 15189, ISO 14971, MDSAP, CLSI guidelines, IEC 62304, IEC 62366-1
Responsibilities
Design and implement fit-for-purpose IVD QMS aligned with ISO 13485 and EU IVDR; Provide strategic quality leadership for regulatory submissions (PMA, 510(k), IDE, NDA, BLA) and conformity assessments; Oversee end-to-end lifecycle quality including assay development, validation, and design transfer; Establish quality frameworks for internal/external laboratories and CROs; Conduct supplier qualification, audits, and monitoring; Manage nonconformance, deviation, CAPA, and post-market performance follow-up systems
Seniority
Senior, hands-on IC
