Sr QA Engineer
Core
Lead complex quality investigations, drive root cause analysis, and ensure regulatory compliance for continuous glucose monitoring (CGM) devices and manufacturing processes.
Role type
Senior Quality Engineering Lead (Medical Devices/Manufacturing)
Builds
CGM devices and biosensing technology for patients with diabetes
Domain
Medical Devices / Consumer Health Technology / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
root cause analysis, Six Sigma, Lean Manufacturing, process capability analysis (Cpk/Ppk), Gage R&R, sampling plans, risk-based problem solving, validation strategies (IQ/OQ/PQ/PV), software V&V, design transfer, data analysis (JMP, Excel), cross-functional leadership
Preferred skills
chemical engineering background, polymers and analytical experience, chemistry in manufacturing
Responsibilities
Lead complex quality investigations and drive systemic corrective actions; Provide technical leadership in quality engineering methodologies; Own validation and qualification strategies for equipment, processes, and software; Serve as quality lead on cross-functional projects; Guide design transfer and commercialization efforts; Assess and mitigate risk by influencing design decisions; Identify and close compliance gaps; Represent Quality during internal audits and external regulatory inspections
Seniority
Senior, hands-on IC with strategic influence