Staff QA Engineer
Core
Technical leader for new high-volume manufacturing automation equipment development, ensuring regulatory compliance and scalable manufacturing readiness for continuous glucose monitoring (CGM) devices.
Role type
Staff Quality Engineer (Manufacturing Automation & Validation)
Builds
Commercial automation deployment for CGM devices and biosensing technology
Domain
Medical Devices / Continuous Glucose Monitoring / Manufacturing Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
FDA 21 CFR 820, ISO 13485, Design Control, Design Transfer, FMEA, Process Validation, Root Cause Analysis, Six Sigma, Statistical Analysis, Data Analysis (JMP/Excel), Risk-Based Design
Preferred skills
Lean Manufacturing, CAPA Strategy, Nonconformance Management, Audit Representation, Cross-functional Leadership
Technologies
JMP, Excel, FMEA, Six Sigma
Responsibilities
Architect validation strategies across programs; drive design transfer strategy for new products; lead complex investigations and MRB decision-making; align multi-level cross-functional teams on compliance topics; govern the Quality Management System; represent the organization during internal audits and external regulatory inspections; mentor engineers and cross-functional partners.
Seniority
Staff, technical leader with mentorship responsibilities