Staff QA Engineer
Core
Lead complex, high-risk quality investigations and drive Quality Management System excellence for continuous glucose monitoring (CGM) devices in regulated manufacturing environments.
Role type
Staff Quality Engineering Technical Lead
Builds
CGM devices and biosensing technology
Domain
Medical Devices / Regulated Manufacturing
Required skills
root cause analysis, risk management, statistical analysis, process capability, validation strategies (IQ/OQ/PQ/PV), measurement system analysis, software V&V, Six Sigma, CAPA, NCMR/MRB, HHE, FMEA, JMP, Excel
Preferred skills
Chemical Engineering background, experience in design transfer and commercialization, ability to influence without direct authority, independent operation in ambiguity
Technologies
JMP, Excel
Responsibilities
Lead complex quality investigations and root cause analysis; Provide technical leadership in risk management and statistical analysis; Drive QMS improvements and validation frameworks; Define risk-based validation strategies for equipment and processes; Represent Quality in internal audits and external regulatory inspections
Seniority
Staff, hands-on technical lead with strategic influence