QA Engineer 2 - Manufacturing
Core
Quality Engineer supporting manufacturing operations for continuous glucose monitoring (CGM) devices, ensuring compliance with regulatory standards and driving process improvements.
Role type
Manufacturing Quality Engineer II
Builds
CGM medical devices
Domain
Medical Device Manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
root cause analysis, statistical data analysis, risk assessment (PFMEA), validation protocol execution, audit support, CAPA development, regulatory compliance knowledge, SQL queries, engineering drawing review, measurement equipment operation
Preferred skills
cross-functional collaboration, mentoring junior engineers, process improvement project leadership
Technologies
MES, ERP, QMS applications, Microsoft Office
Responsibilities
Lead quality engineering activities including Change Orders, NCE/NCMR investigations, and CAPA development; analyze manufacturing data to identify quality trends and drive process improvements; support FDA, ISO 13485, and MDSAP audits; perform manufacturing line audits; execute qualification and validation activities; mentor junior engineers and technicians.
Seniority
Mid-level, hands-on IC