Senior Quality Engineer
Core
Senior Quality Engineer supporting the development, implementation, and maintenance of QMS processes for IVD and software-enabled IVD products, ensuring compliance with regulatory standards and lifecycle requirements.
Role type
Senior IC Quality Engineer (IVD/Medical Device)
Builds
IVD products and software-enabled IVD solutions
Domain
In Vitro Diagnostics (IVD) / Medical Device / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
IVD QMS process design, risk management (ISO 14971), design controls (IEC 62304/62364), change control, CAPA management, audit preparation, supplier quality, technical writing, lifecycle management tools
Preferred skills
Ketryx or similar lifecycle management tools, regulatory submissions support, ASQ CQA/CQE or ISO 13485 Lead Auditor certification
Technologies
Ketryx, ISO 13485, FDA QSR, IEC 62304, IEC 62366
Responsibilities
Execute IVD QMS and product-development activities; draft and maintain SOPs and controlled documentation; serve as Quality representative on cross-functional teams; support design-control processes and risk-management activities; facilitate change control, nonconformance, and CAPA processes; support internal and external audits; compile and analyze Quality metrics; identify process gaps and recommend improvements; support supplier-quality activities.
Seniority
Senior, hands-on IC
