Sr. Quality Engineer, Software
Core
Core team quality representative for design control projects covering new product development and sustaining efforts, ensuring compliance with QMS and regulatory standards.
Role type
Senior Quality Engineer (Software)
Builds
MedTech products and software within a regulated environment
Domain
Medical Technology / Software Engineering
Deliverable
production ML models | product features | dashboards & analysis
Required skills
Quality engineering policies and best practices, Regulatory standards (21 CFR 820, ISO 13485, ISO 14971, IEC 62304), Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics), Corrective and Preventive Actions, Risk Management, Audits/Inspections, Software Verification and Validation, Software development methodologies, Scaled Agile Framework (SAFe)
Preferred skills
None stated
Technologies
None stated
Responsibilities
Manage quality aspects of the design control process including quality planning, verification and validation planning and execution, and risk management; Review design artifacts to ensure compliance with QMS and good documentation practices; Work with program managers to ensure design deliverables are met and products can be commercially released; Ensure effective verification and validation of design specifications and requirements; Review and ensure complete traceability of related design artifacts; Participate in product requirements development, hazard analysis, and design reviews; Drive root cause analysis of failures and structured problem solving; Ensure product technical files and Design History Files are complete and auditable; Drive continuous improvement efforts with cross-functional teams.
Seniority
Senior, hands-on IC