Professional Quality
Core
Conduct quality-related activities to deliver consistent, high-quality documents, services, products, and processes for medical diagnostics instruments.
Role type
Quality Assurance Professional (Medical Devices)
Builds
compliant quality systems, risk management files, validation packages, and design control documentation for diagnostics products.
Domain
Healthcare diagnostics / Medical Devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality System Compliance, Risk Management principles, Complaint Evaluation, Design Control, Documentation & Change Control, Quality Engineering coordination, FDA design controls knowledge, IEC 62304 knowledge, ISO 14971 knowledge
Preferred skills
Software development lifecycle (SDLC) understanding, software testing practices, HP Quality Center (ALM) experience, Serena Business Manager experience, Siemens Teamcenter experience, IBM DOORS experience
Technologies
HP Quality Center (ALM), Serena Business Manager, Siemens Teamcenter, IBM DOORS
Responsibilities
Maintain awareness of industry standards and report non-compliance issues, Apply basic Risk Management principles and participate in risk management file development, Investigate complex complaints with management oversight, Identify areas for process improvement and provide supporting information for changes, Coordinate quality decisions between different quality and engineering groups, Ensure compliant documentation related to area of responsibility
Seniority
Mid-level, hands-on contributor with some project leadership