Manager, Quality Assurance Engineering
Core
Manage quality KPIs, deploy quality programs, and govern production at a contract manufacturer site in Suzhou, China, supporting current operations and new product introductions.
Role type
Manager, Quality Assurance Engineering
Builds
Medical device production (OmniPod platform) at contract manufacturer sites
Domain
Medical Devices / Manufacturing Quality
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
FDA QSR compliance, ISO 13485 standards, IATF 16949 audit experience, team management, defect monitoring, failure analysis, corrective action implementation, Material Review Board management, statistical process control (SPC), Design of Experiments (DOE)
Preferred skills
Automotive/semiconductor industry experience, hazard analysis, engineering principles with statistics
Technologies
SPC tools, DOE tools, database systems
Responsibilities
Maintain quality metrics and ensure compliance with FDA QSR and ISO 13485; Develop and manage quality programs at the contract manufacturer site; Review data to make accept/reject decisions on products and processes; Investigate product defects and implement corrective actions; Supervise quality assurance engineers; Assist with failure and hazard analysis for commercial products.
Seniority
Manager, hands-on leadership